Endo-tracheal tube securement system

ABSTRACT

A system for securing an endo-tracheal tube or other medical article in position upon a patient includes a head contact member, retainer, and attachment members which can be adjustably attached between the head contact member and the retainer. The retainer may include a bite block. Certain embodiments of the head contact member have a concave shape which follows a portion of the patient&#39;s skull and may have a rigid or flexible structure. The attachment member attaches to the retainer which grips the endo-tracheal tube or other medical article.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) to U.S.Provisional Patent No. 60/718,574, filed Sep. 19, 2005, and under 35U.S.C. §120 to U.S. application Ser. No. 11/303,454, filed on Dec. 16,2005, as a continuation-in-part of the latter application. The entirecontents of both applications are hereby incorporated by reference intheir entireties.

In addition, it is noted that U.S. application Ser. No. 11/303,454 is acontinuation-in-part of application Ser. No. 11/194,975, filed on Aug.2, 2005, which is a continuation of application Ser. No. 10/826,689,filed on Apr. 16, 2004, now issued as U.S. Pat. No. 6,948,500 on Sep.27, 2005, which is a continuation-in-part of application Ser. No.10/270,883, filed on Oct. 11, 2002, now issued as U.S. Pat. No.6,796,310 on Sep. 28, 2004, which claims the benefit of U.S. ProvisionalApplication No. 60/328,727, filed on Oct. 11, 2001. Each of theseadditional applications is hereby incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to techniques and systems for securingan endo-tracheal tube or other medical line to a patient. Morespecifically, this invention relates to an anchoring system and relatedtechniques that maintain an endo-tracheal tube in position upon apatient and/or that inhibit migration of the tube within the throat ofthe patient.

2. Description of the Related Art

When an endo-tracheal tube is used with a medical patient, it is commonfor the tube to be secured to the patient by means of adhesive tape.Failing to secure the endo-tracheal tube can result in the migration ofthe tube within the throat of the patient. Such motion is undesirablesince outward motion of the tube can result in the tube moving entirelyout of the airway of the patient, eliminating its effectiveness andpotentially ventilating the patient's gastro-intestinal tract instead ofthe his lungs. Inward motion of the tube is undesirable because it willeventually result in the tube moving down one of the patient's bronchi,preventing air from being ventilated to the other lung. This willquickly lead to the collapse of the unventilated lung. Even slight backand forth motion of the tube within the throat can result intracheomalacia and ultimately in the weakening or collapse of thetrachea, which may require permanent stenting to maintain an openairway. Migration may further result in Ventilator-Associated Pneumonia(VAP). VAP is an airway infection that generally develops more than 48hours after a patient has been intubated and has a high morbidity andmortality rate. VAP is a leading cause of death among patients withhospital-acquired infections, exceeding the rate of death due to centralline infections, severe sepsis, and respiratory tract infections in thenon-intubated patient and prolongs time spent on the ventilator.

In order to avoid these undesirable consequences, it is common to securethe endo-tracheal tube in the proper position upon the patient. Forinstance, a medical practitioner may, after positioning the tubeproperly within the throat of the patient, wrap adhesive tape around thetube and tape it to the patient. Various devices are often used asadaptors for endo-tracheal tubes, and sometimes these devices are tapedto the patient. Other techniques can involve the use of straps which arewrapped around the head of the patient and which connect to the tube, orto the adaptor of the tube.

Such arrangements present certain problems for a medical practitioner.One difficulty is that once secured, it is generally not convenient torelease or adjust the securement of the endo-tracheal tube. Forinstance, if an adhesive is used to secure the tube to the patient,adjusting or re-securing the tube in such situations requires that theadhesive be removed from the patient and the tube, and then freshadhesive be used to properly re-secure the tube upon the patient. Suchadhesive tape can be difficult to work with for medical practitionerswearing latex gloves, and contact with the adhesive can introduce tearsor microscopic perforations into the gloves, compromising theireffectiveness. Furthermore, repeated application and removal of adhesivefrom the face of a patient can irritate the skin of the patient.

Systems that use straps are often difficult to adjust and generallyinvolve complex arrangements that can be difficult to position properlyupon a patient. These systems can be difficult to remove from a patientas well. Furthermore, such systems for retaining an endo-tracheal tubein position often occlude the mouth of the patient. This can prevent ahealth-care worker from having access to the mouth to allow for mouthcare, such as suction of fluid from the oral cavity.

Another problem is that the endo-tracheal tube is deformable and passesbetween the patient's teeth. It is desirable to prevent theendo-tracheal tube from being occluded by a patient's teeth when thepatient attempts to bite down. Occlusion of the endo-tracheal tube canlead to, for example, hypoxia. The restraining approaches discussedabove are ineffective in protecting against possible occlusion of theendo-tracheal.

Therefore, a need continues to exist for an improved system to secure anendo-tracheal tube to a medical patient while inhibiting occlusion ofthe endo-tracheal tube.

SUMMARY OF THE INVENTION

One aspect of the endo-tracheal tube securement system described hereinincludes a head contact member, at least two upper attachment members,and at least two lower attachment members, each attachment memberextending from the head contact member, at least portions of the twolower attachment members being configured to lie below a line connectingthe lips and ear of a patient when the securement system is installedupon the patient. The system further includes a retainer having aposterior facing surface, a channel and a plurality of securinglocations disposed on each side of the channel, the channel beingconfigured to receive a portion of the endo-tracheal tube so as toinhibit movement of the endo-tracheal tube relative to the retainer, andthe posterior facing surface being configured to inhibit movement of theretainer into the patient's mouth, wherein the at least four attachmentmembers are configured to attach to the plurality of securing locationsso as to secure the endo-tracheal tube to the head contact member. Thesystem further includes at least two crossover attachment members, eachattaching one of the at least two upper attachment members to one of theat least two lower attachment members so as to inhibit the at least twolower attachment members from migrating in a downward direction and overthe mandible or jaw bone of the patient.

Another aspect is a securement system that includes a head contactmember comprising a flexible strap in the form of a closed loop, theloop being sized to receive a portion of the skull of a patient suchthat the strap encircles at least the lambda of the skull, the loopbeing sufficiently small to inhibit the skull from passing through theloop and a plurality of upper straps and a plurality of lower strapsattached to the head contact member. The system further includes atleast two crossover attachment members, each attaching one of theplurality of upper straps to one of the plurality of lower straps so asto inhibit the lower straps from migrating in a downward direction andover the mandible or jaw bone of the patient and a retainer attached tothe plurality of upper straps and the plurality of lower straps andconfigured to receive a portion of the medical article so as to inhibitmovement of the medical article relative to the retainer.

Yet another aspect is a method that comprises placing a head contactmember on a patient's head, the head contact member being in contactwith a plurality of securing straps, wrapping the plurality of securingstraps around a portion of the patient's head, the plurality of strapsbeing in contact with a retainer having a first portion and a secondportion and in contact with a plurality of adjustment straps, andengaging the first portion with the second portion so as to inhibitmovement of a medical tube relative to the retainer. The method furthercomprises adjusting the length of one or more of the plurality ofadjustment straps so as to inhibit one or more of the plurality ofsecuring straps from migrating in a downward direction and over themandible or jaw bone of the patient.

Further aspects, features, and advantages of the present invention willbecome apparent from the detailed description of the preferredembodiments that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described with reference to the drawingssummarized below. These drawings and the associated description areprovided to illustrate a preferred embodiment of the invention, and notto limit the scope of the invention.

FIG. 1 illustrates an exemplary endo-tracheal tube and adaptor.

FIG. 2 illustrates one preferred embodiment of a securement system inaccordance with the present invention.

FIG. 3 illustrates a top view of the head pad of the securement systemof FIG. 2.

FIG. 4 illustrates a side view of the head pad of FIG. 3.

FIG. 5 illustrates a front view of the head pad of FIG. 3.

FIG. 5A illustrates a concave shaped head pad.

FIG. 6 illustrates a securing member of the securement system of FIG. 2.

FIG. 7 is an enlarged view of the indicated portion of FIG. 2.

FIG. 8 illustrates an attachable fastener in accordance with anotherpreferred embodiment of the present invention.

FIG. 9 illustrates the attachable fastener of FIG. 8 in use upon anendo-tracheal tube.

FIG. 10 illustrates a tube adaptor having eyelets in accordance withanother preferred embodiment of the present invention.

FIG. 11 illustrates a securing member in accordance with anotherpreferred embodiment of the present invention.

FIG. 12 illustrates the use of the securement system of FIG. 2 in useupon a patient.

FIG. 13 illustrates a tube adaptor having hooks in accordance withanother preferred embodiment of the present invention.

FIG. 14 illustrates a securing member for use with the adaptor of FIG.13.

FIG. 14A illustrates another securing member suitable for use with theadaptor of FIG. 13.

FIG. 15 illustrates an attachable fastener having hooks in accordancewith another preferred embodiment of the present invention.

FIG. 16 illustrates another embodiment of a securement system inaccordance with the present invention.

FIG. 17 illustrates a front view of a head contact member of thesecurement system of FIG. 16.

FIG. 18 illustrates a side view of the head contact member of FIG. 16.

FIG. 19 illustrates a top view of a retainer of the securement system ofFIG. 16.

FIG. 20 illustrates a bottom view of the retainer of the securementsystem of FIG. 16.

FIG. 21 illustrates a side view of the retainer of FIG. 19 having afinger surface.

FIG. 22 illustrates an opposite side view of the retainer of FIG. 19having a second finger surface.

FIG. 23 illustrates a side view of the retainer of FIG. 19.

FIG. 24 illustrates a perspective view of the retainer of FIG. 19.

FIG. 25 illustrates an opposite side perspective view of the retainer ofFIG. 19.

FIG. 26 illustrates a perspective view of a first portion of theretainer of FIG. 19.

FIG. 27 illustrates an opposite side perspective view of the firstportion of the retainer of FIG. 26.

FIG. 28 illustrates a perspective view of a second portion of theretainer of FIG. 19.

FIG. 29 illustrates an opposite side perspective view of the secondportion of the retainer of FIG. 28.

FIG. 30 illustrates the use of the securement system of FIG. 16 upon apatient.

FIG. 31 illustrates a partial enlarged view of the securement system ofFIG. 16 showing a plurality of attachment members attached to each ofthe first and second portions of the retainer at two locations.

FIG. 32 illustrates another embodiment of a securement system inaccordance with the present invention.

FIG. 33 illustrates the use of the securement system of FIG. 32 upon apatient.

FIG. 34 illustrates the use of the securement system of FIG. 32 upon apatient and shows the attachment members aligned with the securinglocations of the retainer.

FIG. 35 illustrates the use of the securement system of FIG. 32 upon apatient and shows the strap head contact member encircling at least aportion of the patient's skull.

FIG. 36 illustrates another embodiment of a securement system inaccordance with the present invention.

FIG. 37 illustrates a top view of a retainer of the securement system ofFIG. 36.

FIG. 38 illustrates a bottom view of the retainer of the securementsystem of FIG. 36.

FIG. 39 illustrates a side view of the retainer of FIG. 37 having afinger surface.

FIG. 40 illustrates an opposite side view of the retainer of FIG. 37having a second finger surface.

FIG. 41 illustrates a side view of the retainer of FIG. 37.

FIG. 42 illustrates a perspective view of the retainer of FIG. 37.

FIG. 43 illustrates an opposite side perspective view of the retainer ofFIG. 37.

FIG. 44 illustrates a perspective view of a first portion of theretainer of FIG. 37.

FIG. 45 illustrates an opposite side perspective view of the firstportion of the retainer of FIG. 44.

FIG. 46 illustrates a perspective view of a second portion of theretainer of FIG. 37.

FIG. 47 illustrates an opposite side perspective view of the secondportion of the retainer of FIG. 46.

FIG. 48 illustrates another embodiment of a securement system inaccordance with the present invention.

FIG. 49 illustrates the use of the securement system of FIG. 48 upon apatient and shows the attachment members aligned with the securinglocations of the retainer.

FIG. 50 illustrates the use of the securement system of FIG. 48 upon apatient and shows the strap head contact member encircling at least aportion of the patient's skull.

FIG. 51 illustrates the use of another embodiment of a securement systemupon a patient and shows a crossover attachment member connecting anupper attachment member to a lower attachment member.

FIG. 52 illustrates the use of another embodiment of a securement systemupon a patient and shows a crossover attachment member fixedly attachedat its ends to both the upper attachment member and the lower attachmentmember.

FIG. 53 illustrates the use of another embodiment of a securement systemupon a patient and shows a multi-piece, crossover attachment member.

FIG. 54 illustrates a top view of another preferred embodiment of aretainer having a bite block in accordance with the present invention.

FIG. 55 illustrates a bottom view of the retainer from FIG. 54.

FIG. 56 illustrates a side view of the retainer of FIG. 54.

FIG. 57 illustrates an opposite side view of the retainer of FIG. 54.

FIG. 58 illustrates a side view of the retainer of FIG. 54.

FIG. 59 illustrates a perspective view of the retainer of FIG. 54.

FIG. 60 illustrates an opposite side perspective view of the retainer ofFIG. 54.

FIG. 61 illustrates a perspective view of a first portion of theretainer of FIG. 54.

FIG. 62 illustrates an opposite side perspective view of the firstportion of the retainer of FIG. 61.

FIG. 63 illustrates a perspective view of a second portion of theretainer of FIG. 54.

FIG. 64 illustrates an opposite side perspective view of the secondportion of the retainer of FIG. 63.

FIG. 65 illustrates another embodiment of a securement system thatincludes a retainer having a bit block in accordance with the presentinvention.

FIG. 66 illustrates the use of the securement system illustrated in FIG.65 upon a patient and shows the bite block disposed between the frontteeth of the upper and lower jaws of the patient.

FIG. 67 is a cross-section view along lines 67-67 in FIG. 66 and showsthe bite block disposed within the patient's mouth and between the lipsand teeth of the upper and lower jaws so as to inhibit the teeth fromcontacting and occluding the endo-tracheal tube.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following description and examples illustrate preferred embodimentsof the present securement system disclosed in the context of use with anexemplary endo-tracheal tube. The principles of the present invention,however, are not limited to endo-tracheal tubes such as those shown. Itwill be understood by those of skill in the art in view of the presentdisclosure that the securement system described can be used with othertypes of medical articles, including, but not limited to: endo-trachealtubes of different design, either with or without tube adaptors,naso-tracheal tubes, and the like. One skilled in the art may also findadditional applications for the devices and systems disclosed herein.Thus, the illustration and description of the securement system inconnection with an endo-tracheal tube is merely exemplary of onepossible application of the securement system and technique disclosed.

The exemplary endo-tracheal tube 10, as shown in FIG. 1, comprises anelongated tubular body 20 with a central lumen. The tube is insertedinto the trachea of a medical patient, generally through the mouth. Theendo-tracheal tube can include an inflatable balloon 30 located on theportion of the tube which is inserted into the throat. In order toprovide the ability to inflate or deflate the balloon, a secondaryinflation lumen 40 can extend from the balloon 30 portion of the tubealong the tubular body 20 and can extend away from the tubular body at alocation which will be located outside the patient at all times. A valve45 is preferably disposed upon the end of this inflation lumen for usein controlling the inflation of the balloon.

As is shown, the endo-tracheal tube 10 can be used with an adaptor 50which is disposed upon the external end of the endo-tracheal tube 10.This adaptor provides a connection between the lumen of the tube and anyother tube or apparatus to which the endo-tracheal tube can beconnected, such as a ventilator.

Overview

As shown in FIG. 2, the securement system 100 described comprises a headpad 110 and one or more securing members 120. The head pad is designedto be placed underneath the head of the intubated patient. The head padcontains a head support 130 upon which the head and neck of the patientwill rest. Disposed on each lateral side of the head pad are one or moreslits 140 or holes through which one end of a securing member 120 can beinserted. In a preferred form, the head pad 110 includes a plurality ofslits 140 and four securing members are attached to the head pad byinserting one end of each member through a slit upon the head pad, andthen affixing them in position, for example via a hook and loop fastenerarrangement (e.g., Velcro®) disposed upon the member. The free end ofeach securing member includes a mechanism to secure the member to theendo-tracheal tube or its adaptor. This can include an adhesive strip, ahook designed to attach to an eyelet upon the tube or adaptor, a clipcomponent designed to engage a corresponding clip component (e.g., areceptacle) disposed on the endo-tracheal tube or adaptor, or such otherfastener as is known to those of skill in the art. These will bediscussed in greater detail below.

Once the patient is intubated and his head is placed upon the head pad110, each of the four members 120 are attached to the tube 10 or tubeadaptor 50. Once the members are attached, they are made snug byreleasing their attachment to the head pad 110 and then re-securing themember 120 to the head pad after pulling the member taut. By thisarrangement, a snug four-point securement can be made between theendo-tracheal tube 10 and the head pad 110, holding the tube in positionupon the patient, and inhibiting undesirable migration of the tubewithin the throat of the patient. The system can easily be removed fromthe patient by releasing the members 120 from the head pad 110, allowingfor quick release, as well as for readjustment of the positioning of thetube.

The above features will now be described in greater detail withreference to the included Figures.

Head Pad

An exemplary head pad 110 for use in the described endo-tracheal tubesecurement system 100 is shown in FIGS. 3 to 5. FIG. 5A illustrates aconcave shaped head pad 110. The head pad 110 comprises a concave baseor platen 150, 150 a. The head pad 110 may further include a headsupport 130 to provided cushioning to the patient. In the embodimentsillustrated in FIGS. 3-5A, the head pad 110 comprises a concave base orplaten 150, 150 a and a head support 130. The head pad 110 illustratedin FIG. 5A comprises a curved or concave shaped base 150 a. Asillustrated by FIGS. 2 and 5A, the head pad 110 can have various shapeswhich allow the head pad to keep the members 120 taut between the backof the patient's head and the tube 10. The contact between the head padand the patient's head region maintains tension in the members 120. Thetension in the members 120 inhibits the tube 10 from undesirablemigration within the throat of the patient.

The head pad 110 can have a shape which follows the natural contour ofthe patient's head or cranium. The head pad 110 illustrated in FIG. 5Ahas a generally concave shape that contacts the patient's head. Whilethe illustrated head pad 110 in FIG. 5A has generally a truncated,cylindrical and concave shape, other shapes can be used. For example,the head pad can have a spherical, dome, or bowl shape which forms acavity to receive the back of the patient's head. In such embodiments,the one or more slits 140 or holes may be arranged around the peripheryof the head pad. As illustrated in FIG. 2, the head pad 110 can have agenerally rectangular shape.

In the embodiment illustrated in FIGS. 3-5, the concave base or platen150 is a generally rectangular plastic piece, which forms the lower bodyof the head pad 110 and which is bent upwardly along two opposite edgesto form the securing regions 160 to which the securing members 120 willbe attached. As shown in FIGS. 5 and 5A, the securing regions 160 extendboth laterally and upwardly from the periphery of the concave base orplaten 150, 150 a. For the embodiment illustrated in FIG. 2, the concavebase or platen 150 is generally sized such that the central rectangularportion of the head pad will extend both beyond the crown and chin of apatient, as well as to each side of the patient's head.

Each securing region 160 has a plurality of slits 140 or holes disposedalong the longitudinal length of the securing region. Each hole is sizedso as to accept one end of a securing member 120. As used herein, theword “end” is not intended to be limited to the actual terminus of aparticular member. “End” is used broadly to refer to not only theterminus of a particular structural element, but also the region of theelement which is near this terminus. While the concave base or platen150, 150 a can include as few as two slits on each securing region (fora total of four slits), it is more desirable that a larger number ofslits be provided upon each securing region so that there are multiplepositions in which each securing member can be attached. Each of thehead pads 110 shown in FIGS. 2 and 5A includes ten slits in eachsecuring region, although those of skill in the art will understand thatthe number of slits 140 can be varied without changing the nature of theinvention.

By providing a greater number of positions to which the members 120 canbe attached to the concave base or platen 150, 150 a, the system canaccommodate a greater variety of sizes of patient's heads with the samehead pad 110. This also allows a particular member to be moved from oneslit 140 to another in order to more effectively secure a medical devicein position upon a patient.

The head support 130 is disposed on top of a portion of the concave baseor platen 150, 150 a. The head support forms a contoured surface thatwill support the head of the patient upon whom the endo-tracheal tube isbeing secured. The head support 130 is desirably somewhat pliant, so asto provide some cushioning to the head of the patient. The head support130 can comprise a generally rectangular foam body when seen from above(see FIG. 3), with a generally flat bottom surface. The head support isgenerally dimensioned so as to fit upon a region of the concave base orplaten 150, 150 a, but not to extend onto the securing regions 160.

The thickness of the head support 130 can vary, and in particular can becontoured so as to provide effective support for the head and neck of amedical patient with the back of the head upon the head support andfacing upwardly away from the platen 150. This can be accomplished bycontouring the head pad 130 such that the region of the support locatedunder the neck of the patient is thicker than the region under the head.In addition, the central region of the pad can be thinner than the sidesso as to provide some lateral support for the head of the patient and toinhibit the head from rolling to either side and possibly dislodging theendo-tracheal tube from its proper position. In addition, the thickerneck support region also inhibits the head from rocking forward with thechin moving toward the chest. This motion can cause undesirablecompression of the cervical vertebrae, as well as resulting in crimpingor undesirable motion of the endo-tracheal tube within the throat of thepatient.

The concave base or platen 150, 150 a can be formed by injection moldingfrom plastic or another suitable material. The head support 130 can beformed from foam or some other pliant material. The head support 130 canbe attached to the concave base or platen 150, 150 a by a layer ofadhesive disposed upon the upper surface of the platen. The bottomsurface of the head support can then be placed upon this adhesive tosecure the pad in position upon the concave base or platen 150, 150 a.

The head support 130 and the concave base or platen 150, 150 a can bothbe formed in the successive stages of the molding process and securedvia adhesive, or they can be manufactured separately and assembledafterward. In addition, it can be desirable in certain applications forthe head pad 110 to be disposable, in which case, materials of lesserdurability can be used for the concave base or platen 150, 150 a andhead support 130.

Securing Members

As shown in FIG. 6, one preferred securing member 120 for use with thehead pad 110 described above comprises an elongated flexible strip 200of material which resists tearing. A variety of textiles can be used,such as a woven cotton-based textile. Woven plastic can also form asuitable material for the securing member. The member 120 is desirablylong enough at least to reach from the edge of the head pad to about themouth of the patient. The member 120 should also have enough additionallength to allow it to be adjusted as necessary, as will be discussedbelow. This length can desirably be between about 10 and 20 inches intotal length, depending upon the application.

One end of the securing member is desirably formed with hook and loopfastener material (e.g., Velcro®) disposed along one surface of themember. This can be seen in FIG. 6. For example, the end of the membercan have the hook portion 210 of the fastener disposed upon the lastportion of one surface, with the loop portion 220 disposed upon theadjacent portion of the same surface. The total size of the portioncovered with hook and loop material can desirably be between 3 and 6inches.

This end of the member 120 is used to attach the securing member to thehead pad 110. The end of the member 120 with the hook and loop fasteneris inserted through one of the slits 140 or holes of the securing region160 of the head pad 110. Once inserted through, the member is foldedaround the edge of the securing region such that the hook portion 210 ofthe fastener is placed into contact with the loop portion 220 of thefastener on the end of the member. When the hooks and loops engage eachother, the member 120 is now secured to the edge of the head pad 110, asshown in FIG. 7, which is an enlarged view of the circled region of FIG.2.

The length of the free end of the member 120 can be adjusted by alteringthe location along the length of the hook and loop fastener at which themember wraps around the edge of the securing region 160 of the head pad110. By pulling the hook and loop portions apart from one another, themember 120 is free to be slid through the slit of the head pad 110. Onceit is pulled to the desired position, the hook portion 210 and loopportion 220 are brought together again and the member is now secured inthe new position upon the head pad 110.

In order to provide a greater degree of adjustment of the overall freelength of the member 120 which extends away from the slit 140 of thehead pad 110, the length of the loop portion 220 of the hook and loopfastener can be extended along the member 120 away from the end with thehook portion 210. This provides a greater range of positions along thelength along the member 120 to which the hook portion 210 can be securedvia the loop portion 220. In particular, with a greater length of themember 120 over which the loop portion 220 extends, the member can beadjusted into a shorter overall length by securing the hook portion 210to the loop portion 220.

The end of the member 120 without the hook and loop fastener includes alayer of adhesive 230 disposed on one side of the member. The portion ofthe member which has the adhesive coating is desirably between 1 and 4inches long. This portion of the member is initially covered with arelease layer 240. The release layer can comprise a paper or plasticlayer which is placed over the adhesive region 230 to inhibitinadvertent contact with the adhesive prior to attachment of the member120 to the endo-tracheal tube 10 or adaptor 50.

Prior to use, the release layer 240 is peeled off of the end of themember, and the adhesive region 230 of the member 120 can then bewrapped around the endo-tracheal tube 10, or otherwise placed in contactwith the tube 10 or its adaptor 50 in order to attach the tube oradaptor to the securing member 120. This process can be performed for asmany or few of the members as is necessary to properly secure the tube.

Once each desired member 120 is secured to the tube 10 or adaptor 50,each member can be made snug by releasing member 120 from the head pad110 where it is secured by the hook and loop fastener. The member canthen be pulled taut to properly restrain the tub 10 in its position uponthe patient. Once taut, the hook and loop fastener can be used asdescribed above to secure the member 120 at its new length to hold thistaut position.

Attachable Fasteners

A variation upon the system described above for securing endo-trachealtubes to a medical patient replaces the adhesive region 230 at the endof the member 120 with a different structure for fastening or connectingthe end of the member to the endo-tracheal tube 10 or its adaptor 50.One such system uses a hook and an eyelet. In order to use such asystem, appropriate eyelets or other rings, receptacles or apertures canbe disposed upon the tube 10 or adaptor 50. Additionally, in someapplications, it can be desirable to create apertures which are formedthrough the wall of the endo-tracheal tube and to which the members canbe attached.

One technique for accomplishing this is to manufacture endo-trachealtubes that have eyelets already molded on the tube. The eyelets arepreferably located such that they are disposed at a location convenientfor one or more of the members 120 to be attached to them. Anothertechnique is to provide a separate set of attachable eyelets that can bequickly attached to a tube or adaptor when they are needed.

One set of attachable eyelets 250 for use with the present securementsystem is shown in FIG. 8. As can be seen, the attachable componentcomprises an elongated plastic or woven strip 260. One side of the stripis covered with an adhesive layer 270, and the adhesive layer is coveredwith a release liner 280 until it is ready for use in order to inhibitunintentional adhesion. If desired, the release liner 280 can be splitso that it can be peeled off in two sections, as shown in FIG. 8. Theopposite side of the strip 260 includes a number of plastic or wovenrings or eyelets 290 through which hooks from the securing members 120can be inserted (described below).

The strip 250 shown in FIG. 8 shows the eyelets 290 arranged such thatthe axis of the opening of the eyelet 290 is normal to the long axis ofthe strip 260. However, those of skill in the art will recognize thatthe axis of the openings in the eyelets 290 need not be oriented in thisdirection. The eyelets 290 could also be oriented perpendicular to thearrangement shown so that the axis of all the eyelets was substantiallyaligned and was parallel to the long axis of the strip 260. Those ofskill in the art will recognize that various angled arrangements for theeyelets are also possible, and that the axis of each eyelet need not beoriented in the same direction.

In order to use the eyelet strip 250, the adhesive layer 270 is exposedby peeling the release layer 280 from the strip 260. Once this region isexposed, the adhesive layer 270 of the strip 120 is then wrapped aroundthe endo tracheal tube 10. This results in the configuration shown inFIG. 9. Once the eyelet strip 250 is mounted upon the endo-tracheal tube10, securing members 120 can be used to connect the eyelets 290 to thehead pad 110 of the securement system.

Those of skill in the art will also recognize that the fastener disposedupon the attachable strip need not be eyelets designed for use withhooks. Other arrangements include but are not limited to: snaps, clips,or such other fasteners as are known to those of skill in the art.

In addition to the system described above, other designs for attachablefasteners are also possible. For instance, rather than having thefastener elements disposed upon a flat strip 260 which is then wrappedaround the endo-tracheal tube, it is possible to have the attachablefastener pre-formed into a short cylindrical piece or ring. Thefasteners can be disposed upon this cylinder so that they form aconfiguration similar to that of the attachable eyelet strip 250 onceattached to a tube, as shown in FIG. 9. Desirably, the cylinder is slitalong its length at a location about its circumference to allow thecylinder to be flexed into a less curved position and then placed intoposition around the tube.

This ring-style attachable fastener can be formed of a flexible materialwhich tends to hold its shape, but which can be flexed or bent by amedical practitioner without fracturing. The desired shape for such afastener is substantially similar to the shape of the strip-styleattachable fastener shown in FIG. 9 once it has been attached to thetube. The cylinder is placed in the desired position longitudinally uponthe tube, and then it is released and allowed to return toward itsoriginal shape. In returning to its original unflexed shape around thetube, the cylinder can grip the outer surface of the tube even withoutthe use of adhesive. Such an arrangement can be advantageous incircumstances where it becomes desirable to reposition the fastenersupon the tube. In order to improve traction between the cylinder and thetube 10, the inner surface of the tube can be roughened, or otherwisetreated with a high friction coating to provide a better grip betweenthe tube and cylinder. This will help inhibit any undesired motion ofthe cylinder upon the tube 10 once the cylinder is in position.

Other variations of fasteners which can be attached or disposed upon thetube or adaptor include flexible clamps to clamp fasteners around theouter surface of the endo-tracheal tube. Those of skill in the art willrecognize that there are a variety of techniques which are applicablefor attaching fastening elements to the endo-tracheal tube.

Tube Adaptor

Another technique for providing appropriate fasteners for the securingmembers is to provide fasteners, connectors or other anchoringreceptacles, such as holes or eyelets, upon the endo-tracheal tubeadaptor. For example, as shown in FIG. 10, eyelets can be disposed uponthe tube adaptor for use with hooks disposed upon the securing members.As shown in FIG. 10, the tube adaptor 300 comprises a generally tubularplastic piece with a generally tapering diameter to its inner lumen 310.One end of the adaptor 300 is provided with a tapered region 320 whichcan be inserted into the end of an endo-tracheal tube 10, while theother end can be connected to an external tube of some kind, forexample, the end of a ventilator.

As shown in FIG. 10, the adaptor 300 also can include suitable anchorsfor attachment to the securing members 120 of the endo-tracheal securingsystem 100. A number of eyelets 330 are shown disposed around thecircumference of the central portion of the tube adaptor 300. Thisregion of the adaptor 300 is between the end 320 of the adaptor that isinserted into the endo-tracheal tube 10, and the end of the adaptor 300that attaches to an external medical tube or device.

As can be seen in FIG. 10, the eyelets 330 can desirably be disposedsuch that each of the axes of the holes of the eyelets are roughlytangential to the circumference of the tube adaptor 300 at the pointwhere the eyelet is attached to the adaptor. Those of skill in the artwill recognize that these eyelets can also be disposed such that theaxes of the eyelets are generally all parallel to the axis of theadaptor 300 itself. In general, the eyelets 330 can be disposed in anyarrangement which is suitable for cooperating with the hooks of thesecuring members 120. For instance, any of the orientations discussedwith respect to the attachable eyelet strip 250 above can also be usedhere.

The number of eyelets 330 or other fasteners disposed on the adaptor 300can vary, but is preferably at least equal to the number of members 120which will be fastened to the adaptor 300. As is discussed above withrespect to the attachable eyelets, a variety of different fasteners canbe disposed upon the adaptor other than eyelets without altering thenature of the system described.

Securing Members with Fasteners

In order to work with eyelets as shown with the attachable eyelet strip250 or the tube adaptor 300 described above, a variation upon thesecuring members 120 described above can be used. One example of anappropriate member suitable for use with the eyelets 290, 330 describedabove is shown in FIG. 11.

The general structure and configuration of the securing member 120 issubstantially the same as that shown in FIG. 6 and described above. Theend of the member 120 which is attached to the head pad 110 isconfigured with hook and loop fasteners, and can be adjusted or releasedas described above. However, rather than an adhesive region upon the endof the securing member not attached to the head pad 110, a hook 350 isattached to the member 120. The hook 350 is dimensioned and configuredto be inserted through an eyelet or other aperture disposed upon the tub10 or adaptor 50, 300. These eyelets or apertures can be part of eitheran attachable eyelet strip 250 or a cylindrical ring with eyelets, asdescribed above. The eyelets or apertures can also be integrally formedwith the tube 10 or the tube adaptor 300.

When securing an endo-tracheal tube using the hooks 350 of thesesecuring members in. combination with either an attachable eyelet strip250 or with an adaptor 300 having eyelets, the hooks 350 are placedthrough the eyelets 290, 330, and then the members 120 are made snug asdescribed above by releasing the loop and hook fastener at the end ofeach member, pulling the member taut, and then re-securing the loop andhook fasteners to hold the member in this taut position.

Those of skill in the art will also recognize that if a fastener systemother than a hook and eyelet combination is used that the hook candesirably be replaced by the appropriate portion of the fastener. Forinstance, if snaps are to be used, a snap receptacle can be disposedupon the securing member, and a snap protrusion can be disposed upon theattachable strip or adaptor.

Operation

As illustrated in FIG. 12, a medical attendant can secure anendo-tracheal tube 10 (or other medical article) to a patient 400 usingthe above-described securement system 100 (or a readily apparentmodification thereof). The medical attendant places the head 410 of thepatient 400 upon the head pad 110 such that the neck of the patient isproperly supported by the head pad 110 and the head 410 is not rotatedtoward either side of the patient's body. This can be performed eitherbefore or after the patient is intubated.

If the securing members 120 are not already attached to the head pad110, they can each be threaded through one of the slits 140 of the headpad 110, and then secured in position via the hook and loop fastener oneach member 120. The securing members 120 can also be moved from oneslit 140 to another in order to provide more appropriate anchoringpoints for the securement of the tube 10 upon the patient 400. Forexample, if the patient is young and has a smaller head, the position ofthe tube can be relatively closer to the end of the head pad than if thepatient were fully grown. In order to accommodate this, it can bedesirable to attach two of the members 120 to the head pad 110 at aposition which is located partway down the length of the head pad,rather than closer to the end of the head pad. By providing multipleslits 140 on each side of the head pad 110, the system 100 canaccommodate a wide variety of sizes of patients.

Once the members 120 are secured properly to the head pad 110, eachmember is attached to the endo-tracheal tube 10 or its adaptor. This canbe accomplished via one of the techniques described above and will varydepending upon the type of fasteners provided upon the tube and members.For instance, if adhesive strips as shown in FIG. 6 are provided uponthe securing members, the release liner 240 is removed and the adhesiveis attached directly to the tube 10 or adaptor, as shown in FIG. 12.

If eyelets or snaps are disposed upon the tube or adaptor, then memberswith hooks or snap receptacles can be used to connect the members to thetube 10 or adaptor 50. In the case where no fastener is disposed uponthe tube 10 or adaptor 50, an attachable fastener such as the attachableeyelet strip 250 described above can be attached to the tube 10 oradaptor as desired.

The connection between the head pad 110 and the tube 10 can be madesecure by releasing the hook and loop side of each member 120 andpulling it snug between the head pad 110 and the tube 10. Once taut, thehook and loop fastener portions 210, 220 are re-secured. Once all themembers 120 are snug, undesirable motion of the endo-tracheal tube 10 isinhibited.

Once secured in the above manner, the oral cavity of the patient 400remains accessible to the medical practitioner. This allows for oralcare such as suction to be performed without the need to remove the tube10 from the patient 400, or to untape or otherwise undo the securementof the tube to the patient.

The described system allows a medical practitioner to adjust theposition in which the tube 10 is secured if any adjustment becomesnecessary. For example, if the tube's position must be adjusted upon thepatient (e.g., if the patient has shifted, or it has been determined thetube is placed too deeply or too shallowly within the patient), this canbe accomplished by the same procedure described above for making themembers snug. The hook and loop fasteners of each member 120 arereleased, the tube 10 is repositioned, and then the members 120 are madesnug and re-secured with the hook and loop fastener.

Similarly, if there is a need to rapidly remove the tube from a patient,the members 120 can be quickly released from the patient 400 by eitherremoving the hooks or other fasteners from the eyelets, or in the casewhere an adhesive attachment is used between the members and the tube,the members 120 themselves can be quickly released from the head pad 110by pulling the hook and loop fasteners open. This allows the members 120to be removed from the head pad 110, and the entire tube 10 with themembers still attached to be removed from the patient 400.

Variations

In addition to the variations described above, it is also possible toconfigure the system to use hook and eyelet pairs where the hooks aredisposed not on the securing members, but on the medical articles to besecured instead. The appropriate eyelets can then be located on the freeend of the securing members. In this way, the same securing operation asdescribed above with respect to hook and eyelet fasteners can be used.

By placing the hooks in a fixed position upon the medical articles to besecured, such as the endo-tracheal tube or its adaptor, the free ends ofthe securing members need only include an eyelet or other aperture. Thiscan simplify the manufacture of the members, and can also presentcertain safety advantages. Examples of such variations including thesefeatures are illustrated in FIGS. 13 to 15 and described below.

FIG. 13 illustrates an exemplary endo-tracheal tube adaptor 450 thatincludes hooks 460 suitable for use with securing members 120 thatinclude eyelets or other apertures. If such an adaptor 450 is used withan endo-tracheal tube 10, the securing members 120 of the securingsystem can be attached to the hooks 460 on the adaptor 450.

An appropriate securing member 120 for use with such hooks 460 isillustrated in FIG. 14. The free end of the securing member 120 isillustrated, and includes an opening 480, such as a hole or aperture, inthe end of the member 120. The opening 480 is dimensioned to accept thehooks 460 on the adaptor 450 or other medical article to be secured. Theopening on the member 120 can simply be a hole which is disposed nearthe end of the member, or can include a grommet or other support for theopening which helps inhibit any stretching or tearing of the member dueto the pressure exerted between the hook 460 and the member 120.

As illustrated in FIG. 14A, the securing member 120 can also include aplurality of openings 480 in order to allow for simpler or more rapidadjustment of the connection between the head pad 110 and the medicalarticle being secured. A member 120 including four openings isillustrated, but it will be understood by those of skill in the art thatthe number of openings 480 can be either greater or less than fourwithout altering the nature of the system described.

Although the adaptor 450 shown in FIG. 13 has four hooks 460 disposedaround the upper lip of the adaptor, the adaptor can also be configuredwith either a greater or lesser number of hooks. The position anddirection of the hooks 460 can also be altered from that shown in theconfiguration of FIG. 13.

For instance, FIG. 13 shows the hooks 460 disposed radially about theupper surface of the adaptor. However, it is also possible to use anadaptor on which the hooks 460 are disposed from opposite sides of theupper surface of the adaptor, for example, two hooks extending from eachof a pair of opposite lateral sides of the adaptor. Other possiblearrangements include providing a greater number of hooks, for examplesix hooks disposed about the adaptor. Such an arrangement can beparticularly well suited to adaptors which have a hexagonal upper lip.It is also possible to use an adaptor upon which the hooks arepositioned at a location below the upper surface, similar to theposition shown for the eyelets 330 in FIG. 10.

As described above with respect to the eyelet on the tube or adaptor,the individual hooks can be disposed such that the curved portion of thehooks extend in a plane normal to the axis of the tube, rather thanextending in a plane parallel to the axis of the tube (as shown in FIG.13).

In addition to the illustrated tube adaptor 450 with hooks 460 shown inFIG. 13, the securing members 120 of FIGS. 14 and 14A can also be usedwith an endo-tracheal or other tube which is integrally formed toinclude one or more hooks. These can be disposed in substantially thesame positions and arrangements as the eyelets 290 are disposed upon thetube in FIG. 9. Similarly to what is described above, the hooks need notextend in a plane strictly normal to the axis of the tube, but can bedisposed in a plane parallel to the axis of the tube.

For use with tubes 10 that do not have hooks molded upon them, anattachable fastener 500 with hooks 510 can be provided. Such anattachable fastener, as shown in FIG. 15, is substantially as describedabove with reference to FIG. 8. However, rather than including one ormore eyelets disposed along the fastener, one or more hooks 510 areprovided. Although the attachable fastener 500 shown in FIG. 15 hashooks which extend along the length of the fastener, it will beunderstood that the hooks can extend across the width of the fastenerwithout altering the nature of the system described.

FIG. 16 illustrates another preferred embodiment of a securement system600. The securement system 600 includes a retainer 602 which is securedupon the face of a patient by a harness 604. The harness 604 retains theretainer 602 in the operative position to support an endo-tracheal tube.The harness 604 which secures the retainer 602 to the patient's faceincludes a head contact member 606 and attachment members 608 for use inthe described securement system 600. In the exemplary embodimentillustrated in FIG. 16, the head contact member 606 includes securingregions 610 a, 610 b, 610 c, 610 d extending from the head contactmember 606. The securing regions 610 a, 610 b, 610 c, 610 d are spacedaround the circumference of the head contact member 606 and formreceiving slots for the attachment members 608. The securing regions 610are configured to receive respective attachment members 608, and eachincludes at least one opening arranged so as to be accessible from aside of the head contact member 606.

Each attachment member 608 comprises a first end portion and a secondend portion. In certain embodiments, the end portions each comprise hookand loop fasteners. The first end portion of the attachment member 608is configured for attachment to the retainer 602. The second end portionof the attachment member 608 is configured for attachment to thesecuring regions 610 of the head contact member 606. For example, theopenings in the securing regions 610 receive respective second ends ofthe attachment members 608 by passing each second end through an openingand then attaching the hook region of the hook and loop fastener to theloop region of such fastener. In certain embodiments, at least a portionof each attachment member 608 comprises a flexible elastic material. Forexample, the attachment member 608 may comprise VELSTRETCH made byVelcro USA Inc. located in New Hampshire.

The retainer 602. comprises a first portion 612 and a second portion614. The first portion 612 is configured to engage with the secondportion 614 forming a channel 616 therebetween (see FIG. 19). Thechannel 616 is configured to receive a portion of the endo-tracheal tube10 and to retain the tube 10 so as to inhibit movement of theendo-tracheal tube 10 relative to the retainer 602 (see FIG. 30). Incertain embodiments, the first retainer portion 612 releasably engageswith the second retainer portion 614.

The retainer 602 includes a plurality of securing locations 618 locatedon the first and second portions 612, 614 (see FIG. 19). Each of thefirst and second portions 612, 614 comprises at least one securinglocation 618. In the embodiment illustrated in FIG. 19, each portionincludes two securing locations 618. The securing locations 618 compriseopenings configured to receive the first end portions of the attachmentmembers 608. The width of the securing location 618 may be sized toaccommodate the width of the attachment member 608. For example, thewidth of the attachment member 608 can be equal to or less than thewidth of the securing location 618 to facilitate threading of the endsof the members 608 through respective openings of the securing locations618. In certain embodiments, the securing locations 618 are locatedsuperior and inferior to the lips of the patient when the retainer 602is placed upon the patient's mouth.

The retainer 602 has a posterior facing surface which faces the patientand inhibits longitudinal movement of the retainer 602 into thepatient's mouth. In certain embodiments, the posterior facing surface620 contacts the patient superior and inferior relative to the midlineof the lips and is configured to allow access to the sides of the mouth.

To enhance patient comfort, the posterior surface 620 may comprise asoft padding portion 621 of foam rubber or similar material. The paddingportion 621 contacts the patient's face and bears upon the upper andlower lips to provide firm retainer support while cushioning the mouthand lips of the patient. The padding portion 621 is sufficiently softand flexible to accommodate variations between the profile of retainer602 and the patient's face, thereby distributing contact forces andminimizing the trauma of extended periods of localized higher contactforce.

While not illustrated, the first and second portions 612, 614 caninclude an adhesive and/or suture holes to secure the retainer 602 tothe patient's face. For example, a hydrocolloid adhesive or zincoxide-based adhesive can advantageously be used upon the posteriorfacing surface 620 for attaching the retainer 602 to the skin of thepatient. The hydrocolloid or zinc oxide-based adhesive can be usedeither alone or in combination with another medical grade adhesive.

FIG. 17 illustrates a front view of the head contact member 606 of thesecurement system of FIG. 16, which shows the surface of the headcontact member 606 that contacts the patient's skull. FIG. 18illustrates a side view of the head contact member 606. The head contactmember 606 comprises a curved or concave base. While the illustratedhead contact member 606 has generally a concave shape, other shapes canbe used. In certain embodiments, the head contact member 606 has a shapewhich follows at least a portion of the natural contour of the patient'sskull. For example, the head contact member 606 can have a truncatedcylindrical shape or a spherical, dome, or bowl shape which forms acavity that matches the contour of the back of a human skull. In suchembodiments, the securing regions 610 may be arranged around theperiphery of the head contact member 606.

The head contact member 606 may further include a pad to providecushioning to the patient. The pad can have various thicknesses whichallow the head contact member 606 to keep the attachments members 608taut between the back of the patient's head and the retainer 602. Theattachment members 608 may include an elastic material which alone or incombination with the pad allows the head contact member 606 to keep theattachments members 608 taut between the back of the patient's head andthe retainer 602. In use, the length of each attachment member 608 isadjusted to place them in tension. The contact between the head contactmember 606 and the patient's head region maintains tension in theattachment members 608. The tension in the attachment members 608coupled with the pressure of the posterior surface 620 against thepatient's face inhibits movement of the retainer 602 relative to thepatient, and thus, secures the retainer endo-tracheal tube 10 inposition within the throat of the patient.

In the embodiment illustrated in FIGS. 17 and 18, the concave base, whenviewed from the side (FIG. 18), is a generally hemispherical, singlepiece of plastic that includes the securing regions 610 to which theattachment members 608 may be attached. When viewed from the bottom(FIG. 17), the base has a generally circular central portion, with downand outward extending tabs of the head contact member 606 forming thesecuring regions 610 c, 610 d. For the embodiment illustrated in FIGS.16 through 18, the head contact member 606 is generally sized such thatthe central portion, when positioned on the skull with the attachmentmembers 608 in tension, places pressure on the occipital bone andpreferably also on the parietal bone.

Each securing region 610 a, 610 b, 610 c, 610 d has a slit or hole. Eachhole is sized so as to accept the second end portion of the attachmentmember 608. As used herein, the word “end” is not intended to be limitedto the actual terminus of a particular member. “End” is used broadly torefer to not only the terminus of a particular structural element, butalso the region of the element which is near this terminus. In certainembodiments, the securing regions 610 comprise a first plurality ofsecuring regions 610 a, 610 c and a second plurality of securing regions610 b, 610 d. In the illustrated embodiment, the first plurality ofsecuring regions are disposed on a first side of the head contact member606 and the second plurality of securing regions are disposed on asecond side of the head contact member 606. While the head contactmember 606 can include as few as two securing regions on each side(e.g., a total of four slits), more securing regions may be provided sothat there are multiple positions in which each attachment member 608can be attached. Those of skill in the art will understand that thenumber of slits can be varied without changing the nature of theinvention.

The head contact member 606 may be sized for the patient's head. Forexample, an appropriately sized head contact member 606 may be selectedbased on the patient being an adult or child. By providing multiplesized head contact members 606, the system can accommodate a greatervariety of sizes of patients' skulls while using the same attachmentmembers 608.

The head contact member 606 of the disclosed embodiment forms acontoured surface that will support the head of the patient upon whomthe endo-tracheal tube 10 is being secured. The head contact member 606is desirably somewhat pliant, so as to provide some cushioning to thehead of the patient. The head contact member 606 can be formed byinjection molding from plastic or another suitable material.

FIG. 19 illustrates a top view (i.e., the side facing away from thepatient) of a two piece retainer 602 of the securement system of FIG.16. FIG. 20 illustrates a bottom view (i.e., the side facing towards thepatient) of the retainer 602. The retainer 602 fastens or connects tothe endo-tracheal tube 10. The securing locations 618 attach to theattachment members 608.

The retainer 602 shown in FIG. 19 shows the securing locations 618arranged such that the plane of the opening of the securing locations isparallel to the posterior surface 620 of the retainer 602. However,those of skill in the art will recognize that the plane of the openingsneed not be oriented in this direction. The openings could also beinclined relative to the posterior or bottom surface. Those of skill inthe art will also recognize that various angled arrangements for thesecuring locations 618 are also possible, and that the planes of theopenings for the securing locations 618 need not be oriented in the samedirection relative to the posterior surface 620.

In order to use the retainer 602, the first portion 612 and the secondportion 614 are separated. Once separated, the first portion 612 and thesecond portion 614 are aligned with the endo-tracheal tube 10therebetween (see FIG. 31 without the tube). The endo-tracheal tube 10may first be placed, for example, within the groove or channel portion616 formed by the first portion 612. The second portion 614 is thenengaged with the first portion and completes the channel 616. Thedesired channel shape for such a retainer is substantially similar tothe shape of the endo-tracheal tube 10.

With the first and second portions engaged, the retainer is disposedupon the endo-tracheal tube 10 and results in the configuration shown inFIG. 30. Once the retainer 602 is mounted upon the endo-tracheal tube 10and the head contact member 606 is placed on the opposite side of thepatient's skull, the attachment members 608 can be used to adjust thetension between the retainer 602 and the head contact member 606.

Those of skill in the art will also recognize that the openings of thesecuring locations 618 need not be designed for use with attachmentmembers 608 in the form of straps. Other arrangements include but arenot limited to: snaps, clips, or such other fasteners as are known tothose of skill in the art.

The retainer 602 can be formed of a flexible material which tends tohold its shape, but which can be flexed or bent by a medicalpractitioner without fracturing. Suitable ridged but flexible materialsinclude, for example, but without limitation, plastics, polymers orcomposites such as polypropylene, polyethylene, polycarbonate,polyvinylchloride, acrylonitrile butadiene styrene, nylon, olefin,acrylic, polyester, as well as moldable silicon, thermoplastic urethane,thermoplastic elastomers, thermoset plastics and the like. Theillustrated retainer 602 preferably is formed by injection molding usingpolyethylene or polypropylene material or nylon. However, othermaterials can be utilized, and the first and section portions of theretainer 602 may each be formed as a single piece.

FIG. 21 illustrates a side view of the retainer of FIG. 19 having afirst finger pressure surface 622. FIG. 22 illustrates an opposite sideview of the retainer of FIG. 19 having a second finger pressure surface624. The first and second finger surfaces 622, 624 provide regions for amedical attendant to squeeze the first portion 612 and the secondportion 614 together to form the retainer 602. The retainer 602 is firstplaced in the desired position longitudinally upon the endo-trachealtube 10. The retainer is then squeezed around the endo-tracheal tube 10so as to grip the outer surface of the endo-tracheal tube 10 evenwithout the use of adhesive. Such an arrangement is advantageous incircumstances where it becomes desirable to reposition the retainer 602upon the endo-tracheal tube 10.

In order to improve traction between the retainer 602 and theendo-tracheal tube 10, the outer surface of the endo-tracheal tube 10can be roughened, or otherwise treated with a high friction coating toprovide a better grip between the endo-tracheal tube 10 and retainer602. This will help inhibit any undesired motion of the retainer 602upon the endo-tracheal tube 10 once the retainer 602 is in position.

FIG. 23 illustrates a side view of the two-piece retainer of FIG. 19with a first portion 612 engaged with a second portion 614. Each of thefirst and second portions 612, 614 is a one-piece molding of plasticsmaterial. Each portion 612, 614 includes a groove as described below. Asbest illustrated in FIGS. 21 through 23, the posterior surfaces 620(facing the patient) are preferably contoured. The contour may beselected to follow the curvature of the patient's face. Advantageously,a contoured surface that follows the curves of the patient's faceincreases the contact area between the retainer 602 and the patient'sface and evenly distributes the weight of the retainer 602 and anytension from the attachment members 608.

FIGS. 26 and 27 illustrate perspective views of a first portion 612 ofthe retainer of FIG. 19. The first portion 612 comprises an anchor foot626 (see FIG. 23), a pair of transversely extending parallel flexibleprongs 628, 630, and the securing locations 618. The prongs 628, 630 arepreferably integrally formed with the first portion 612. In FIGS. 19,21, and 23, prongs 628, 630 are shown engaged with the second portion614 to secure an endo-tracheal tube 10 in place.

FIGS. 28 and 29 illustrate perspective views of a second portion 614 ofthe retainer of FIG. 19. The second portion 614 comprises an anchor foot632 (see FIG. 23), a pair of transversely extending parallel receptaclesor apertures 634, 636, and securing locations 618. The receptacles 634,636 are configured to receive the prongs 628, 630 of the first portion612. In the illustrated embodiment, the anchor feet 626, 632 (see FIGS.19 and 23) desirably include a pair of opposing concave sections thatnarrow the center of the anchor feet 626, 632 proximate to the center ofthe retainer 602. As a result, the narrow regions of the anchor feet626, 632 provide clearance to access the sides of the patient's mouthfor oral care and other nursing care as required. The wide regions ofthe anchor feet 626, 632 provide support and stability above and belowthe patient's mouth.

The two portions 612, 614 are adapted to be engaged, as shown in FIG.19, so as to define a tubular channel 616 therebetween for receiving theendo-tracheal tube 10. The channel 616 is formed by respective generallyhemispherical grooves in the first and second portions. Once engaged,the first and second portions are laterally slidable together so as toreduce the channel 616 cross-sectional area and firmly grip theendo-tracheal tube 10. The first and second portions are inhibited fromsliding apart by interengaging structure as described below.

Each groove has a generally hemispherical cross-sectional shape. As bestseen in FIGS. 24 and 25, the groove has a uniform width along thelongitudinal axis. In certain embodiments, the groove varies in width(i.e., in the lateral direction) along its longitudinal length. That is,in certain embodiments, the side walls of the groove diverge from eachother in, for example, a generally linear manner from one longitudinalside of the retainer 602 to the other longitudinal side of the retainer.

To firmly hold the endo-tracheal tube 10 within the channel 616, theretainer 602 includes interengaging structure. The interengagingstructure inhibits the first portion 612 and second portion 614 fromslidingly disengaging from one another. The interengaging structure maybe releasable or not.

In the illustrated embodiment and as best seen in FIGS. 26-29, theinterengaging structure is a releasable latch mechanism. The latchmechanism is used to secure the first portion 612 to the second portion614. In the illustrated embodiment, the latch mechanism comprisesinterfitting teeth 638 (see FIGS. 26 and 27) provided on prongs 628, 630and a pair of receptacles 634, 636 (see FIGS. 28 and 29) ofcomplementary shape to the prongs. Each receptacle 634, 636 includes aninner edge which locks with the teeth 638 on the prong 628, 630. Theinner edges of the receptacles 634, 636 snap against the teeth 638 whenthe prongs 628, 630 are inserted through the receptacles 634, 636forming the closed position. In the illustrated embodiment, the latchmechanism is formed with the retainer 602 as a unitary piece.

In FIG. 21 the prongs 628, 630 are shown inserted through thereceptacles 634, 636. The prongs 628, 630 interact with the receptacles634, 636 formed in the second portion 614 to secure the prongs 628, 630in their operative positions inhibiting the first portion 612 frommoving away from the second portion 614.

FIGS. 24 and 25 illustrate perspective views of the retainer 602 of FIG.19. As seen in FIG. 25, prongs 628, 630 have been inserted throughreceptacles 634, 636 and the prong teeth 638 engage with correspondingedges or teeth on the second portion 614 to clamp the endo-tracheal tube10 in place within the channel 616.

The prong teeth 638 or serrations may be on both sides of the prongs628, 630 to increase holding strength. In the illustrated embodiment,the teeth 638 are arranged on the side of the prongs 628, 630 facingaway from the longitudinal axis while the inner edges of the receptacles634, 636 are arranged on the sides of the receptacles facing thelongitudinal axis; however, these components can be flip-flopped. In aflip-flopped arrangement, outward pressure is applied to the prongs 628,630 to disengage the teeth 638 from the edges in the receptacles 634,636. Of course other interengaging structure known to one havingordinary skill in the art could be used. For example, Velcro, snaps,clips or the like could be employed to secure the first and secondportions 612, 614.

An entrance of the receptacle 634, 636 may include chamfer edges. Thechamfer edges slope inward toward the center of the receptacle to causethe teeth 638 to bend inward when inserting the prong into thereceptacle.

In operation, the ends of the prongs 628, 630 bend toward thelongitudinal axis of the retainer when inserted into the receptacles634, 636. The relatively thin strip of material forming each prong 628,630 allows the prong to bend when finger pressure is exerted on thefinger surface 622, 624 (see FIGS. 27 and 29) to close the retainer. Theinteraction between the teeth 638 and the corresponding edge surface ofthe receptacle 634, 636 holds the prongs 628, 630 in the closed positionand, once engaged, inhibits migration of the first portion 612 away fromthe second portion 614.

For embodiments having releasable interengaging structure, the structureis simply released to remove and replace an endo-tracheal tube 10 withinthe channel 616 of the retainer 602. In certain embodiments, a medicalattendant presses downward on platforms 644 (see FIGS. 24 and 25) todisengage the prongs 628, 630 from the inner edges and slides the firstportion 612 away from the second portion 614. The platforms 644 pivottowards the longitudinal axis and contact the outer surface of theprongs 628, 630. Further pressure on the platforms 644 deflects theprongs 628, 630 away from the edges of the receptacles 634, 636 andtowards the longitudinal axis. As the prongs 628, 630 move towards thelongitudinal axis, the teeth 638 disengage from the edges of thereceptacles 634, 636 releasing the first portion 612 from the secondportion 614. While maintaining pressure on the platforms 644, themedical attendant separates the first portion 612 from the secondportion 614. The medical attendant can then open the retainer 602 andexpose the channel 616.

The same retainer 602 may be used multiple times, so as to permitrepeated attachment and reattachment of the endo-tracheal tube 10 to thesecurement system 600. In addition, the medical attendant can use theretainer 602 with any of a wide variety of size tubes. In addition, thelatch mechanism being integral with the retainer 602 ensures that thelatch mechanism will not be lost or misplaced if the endo-tracheal tube10 is detached from the securement system 600.

The grooves formed in the first and second portions 612, 614 define thechannel 616 when the retainer 602 is in a closed position. The channel616 is capable of receiving a portion or length of the endo-trachealtube 10 and is generally configured to house, grip and secure theaffected endo-tracheal tube 10 in a contact area of the channel 616. Thechannel 616 can have a variety of configurations, as discussed above inconnection with the grooves in order to accommodate a particular tube.As the interengaging structure provides multiple positions, and thusmultiple channel widths, to lock the first portion 612 to the secondportion 614, a single retainer 602 may accommodate many different sizetubes. In the illustrated embodiment, the channel 602 generally has atruncated, circular, cross-sectional shape at its proximal end anddistal end. In certain embodiments, the channel smoothly tapers incross-sectional size from a smaller proximal end to a larger distal end.In such embodiments, the channel 602 generally has a truncated V-shapeand preferably corresponds to the shape of the retained portion of theendo-tracheal tube 10 or medical device.

In the embodiment illustrated in FIGS. 21-25, the sides of the channel602 are generally straight and parallel with each other. The walls ofthe channel 616 (and, thus, the grooves of the first portion 612 andsecond portion 614), however, need not be straight. For example, thewall of the first portion groove can have a convex section that narrowsthe portion of the channel so as to correspond in shape to the shape ofthe received portion of the endo-tracheal tube 10. This channel shapefurthers retention of the endo-tracheal tube 10 within the channel 616to inhibit endo-tracheal tube 10 movement through the channel, asdiscussed below.

Although the channel 616 can take the form of various shapes dependingupon its application (i.e., depending upon a shape of the tube portionof the medical article for which the retainer is designed to be used),the channel 616 does have a sufficient length in the longitudinaldirection to stabilize the endo-tracheal tube 10, rather than act as afulcrum for the endo-tracheal tube 10. That is, the retainer 602receives a sufficient length of the endo-tracheal tube 10 to inhibitmovement of the endo-tracheal tube 10 in the lateral, longitudinal andtransverse direction (i.e., to inhibit yaw, pitch and axial movement ofthe tube), without kinking the endo-tracheal tube 10.

When the first portion 612 is engaged with the second portion 614, asection of the endo-tracheal tube 10 is captured within the retainer602. Thus, the retainer 602 at least restricts, if not prevents, lateraland transverse movement of the retained section of the endo-trachealtube 10.

In certain embodiments, inhibiting movement of the endo-tracheal tube 10in the longitudinal direction when the endo-tracheal tube 10 is securedwithin the channel 616 is desirably enhanced by one or more retentionmechanisms associated with the contact area of the channel 616. One suchretention mechanism involves the shape of the channel 616 itself. Theinteraction between the shape of the channel 616 and a correspondingshape of the endo-tracheal 10 may inhibit longitudinal movement.

The interaction between the contact area on the channel 616 and theendo-tracheal tube 10 creates friction to inhibit longitudinal movementthrough the channel 616. The degree of interference between theendo-tracheal tube 10 and the retainer 602, however, is preferably notso great as to significantly occlude the endo-tracheal tube 10.

Another retention mechanism to inhibit longitudinal movement of theendo-tracheal tube 10 involves one or more securement barbs 642 (seeFIGS. 24 and 25) located on the contact area of the channel 616. Thesecurement barbs 642 can be used to retain the endo-tracheal tube 10 inthe longitudinal direction. In certain embodiments, each barb has agenerally conical shape with a blunt tip. The barb may extend into thechannel 616 by an amount ranging between about 0.1 mm and about 3 mm.

The securement barbs 642 may be arranged within the channel 616 tocooperate with one another. The barbs 642 advantageously are arrangedwithin the same general lateral plane (i.e., a plane defined by thelateral and transverse axes), and are spaced apart from one another. Inaddition, the barbs 642 desirably are spaced on generally oppositecontact areas on the channel 616 in a staggered arrangement. That is,the position of the barbs alternates between the first portion 612 andthe second portion 614 in the lateral direction. The resultingoverlapping pattern of the barbs securely holds the endo-tracheal tube10 without imparting torque to the endo-tracheal tube 10 if pulled in alongitudinal direction.

Another retention mechanism to inhibit longitudinal movement of theendo-tracheal tube 10 involves one or more friction ridges located onthe contact area of the channel 616. The ridges may be integrally formedwith the first and second portions and project into the channel 616. Theridges are desirably of smooth solid construction; however, they can beof hollow construction. The ridges can have generally triangularcross-sectional shapes and angle toward one or both ends of the channel616. The ridges, however, can have other cross-sectional shapes whichwould interfere with longitudinal movement of the endo-tracheal tube 10through the channel 616.

In certain embodiments having friction ridges, each of the ridgesdesirably has a front wall or leading edge that forms an angle of lessthan 90 degrees as measured between the front wall and the channelsurface. The ridges slightly protrude into the channel 616, desirably ata transverse distance of between 0.1 to 10 mm for the given application.The ridges also lie generally normal to a longitudinal axis through thechannel 616.

When so arranged, the friction ridges gently, but securely bite or pressinto an outer surface of the endo-tracheal tube 10. Such contactpreferably does not significantly occlude or otherwise meaningfullyimpair air flow in the endo-tracheal tube 10 because of the compliantnature of the endo-tracheal tube 10 material and because of the degreeto which the ridges bite into the endo-tracheal tube 10. This degree ofcontact, however, coupled with the angular orientation of the ridgesinhibits movement of the endo-tracheal tube 10, especially in adirection opposite of that in which the ridges are angled.

Another possible retention mechanism to improve traction between theretainer 602 and the endo-tracheal tube 10 involves roughening theinside of the channel 616. The inside of the channel 616 can beroughened, or otherwise treated with a high friction coating to providea better grip between the endo-tracheal tube 10 and retainer 602. Thiswill help inhibit any undesired motion of the retainer 602 upon theendo-tracheal tube 10 once the retainer 602 is in position.

Another possible retention mechanism to inhibit axial movement of theendo-tracheal tube 10 relative to the retainer 602 involves an adhesivespot. An adhesive spot may be advantageously disposed upon the inside ofthe channel 616. The adhesive spot may take the form of a glue dot. Suchglue dots are desirably formed of a material which exhibits highresistance to shear and which can be peeled off of the catheter withoutleaving a residue. Such an adhesive is sold by All-Pak Inc. of NewBerlin, Wis. as part number GD-06 “Super High Tack Glue Dot.” Multipleglue dots may be used, or a single glue dot may be disposed on only oneside of the channel of the retainer 602. It is ordinarily not necessaryfor multiple glue dots to be used; a single glue dot disposed uponeither the first or second portions may advantageously be used toprovide greater frictional and transverse forces between the retainer602 and the endo-tracheal tube 10.

Furthermore, the adhesive spot need not be a single point of adhesive.In certain embodiments, the adhesive spot is a region composed of anelastic and compressively deformable material such Kraton polymercompounds. Such a compound includes Dynaflex G2706 available from GLSCorporation, as well as other thermoplastic elastomers or silicone orurethane epoxies.

This region also need not be round. In certain embodiments, a largeregion of the surface of the channel 616 may be covered with a suitablematerial, such as Kraton. For instance, the entire channel surface onthe first portion 612 might be covered with a thin layer of adhesive toadvantageously provide additional traction and transverse bias betweenthe endo-tracheal tube 10 and retainer 602.

Other means of producing an appropriate adhesive spot for use withvarious embodiments include without limitation: treating a portion ofthe surface of the channel chemically or electrically to adjust itssurface friction or compressibility; spraying or spreading an adhesivecoating onto a portion of the channel; attaching peel-off adhesivemembers to portions of the channel; injection molding regions ofadhesive or compressible material, such as Kraton, to a portion of thesurface of the channel; or such other means as are known in the art.

FIG. 30 illustrates the use of the securement system 600 of FIG. 16 upona patient. FIG. 31 illustrates a partial enlarged view of the securementsystem 600 of FIG. 16 showing a plurality of attachment members 608attached to each of the first and second portions of the retainer 602 attwo locations. A medical attendant can secure an endo-tracheal tube 10(or other medical article) to a patient using the above-describedsecurement system (or a readily apparent modification thereof). Themedical attendant opens the retainer 602 to expose the grooves on thefirst and second portions 612, 614. The medical attendant places thepatient's head on the head contact member 606 or brings the head contactmember 606 in contact with the patient's head.

The medical attendant wraps the attachment members 608 around a portionof the patient's head and towards the patient's face. The first endportion of the attachment member 608 is attached to the retainer 602.Two attachment members 608 attach to the first portion 612 while twoother attachment member 608 attach to the second portion 614. The secondend portion of the attachment member 608 is attached to the securingregions 610 of the head contact member 606. Preferably, the attachmentmembers 608 are attached to the head contact member 606 before beingattached to the retainer 602.

With the retainer open, an endo-tracheal tube portion can betransversely aligned between the grooves in the retainer 602. Themedical attendant generally aligns the first portion 612 with the secondportion 614 as illustrated in FIG. 31 with the endo-tracheal tube 10being located therebetween. Once the endo-tracheal tube 10 is so alignedand placed between or in a groove, the retainer is closed and latched byengaging the prongs 628, 630 of the first portion with the receptacle634, 636 of the second portion 614. When in the closed position, theinterengaging structure inhibits movement of the medical endo-trachealtube 10 relative to the retainer 602.

If the retainer employs projections that clamp onto or pin theendo-tracheal tube 10 within the channel 616, then this engagementbetween the retainer and the endo-tracheal tube 10 would further securethe endo-tracheal tube 10 in place. If the endo-tracheal tube 10 ispulled in the distal direction, the securement barbs bite into theendo-tracheal tube 10 and also oppose movement of the endo-tracheal tube10 in this direction.

The retainer 602 thus inhibits longitudinal movement of theendo-tracheal tube 10 relative to the retainer. The holding effectprovided by each of the retention mechanisms, however, does notsignificantly occlude the endo-tracheal tube 10. And although thesecurement barbs bear against the endo-tracheal tube 10, their limitedbite does not significantly occlude or penetrate the endo-tracheal tube10.

The retainer 602 can include only one retention member or possiblyseveral; it need not include any at all. In addition, any combination ofthe retention members (for example, an adhesive spot and secure barbs)in the retainer is also possible.

When in place, the lower two attachment members 608 are disposed beneaththe ears, while the upper two attachment members 608 are above the earsand cross over the temples of the patient. Further, the lower twoattachment members 608 are attached to the retainer 602 below the lipline while the upper two attachment members 608 are attached to theretainer 602 above the lip line.

FIG. 32 illustrates another preferred embodiment of a securement system700. FIG. 33 illustrates the use of the securement system 700 of FIG. 32upon a patient. The securement system 700 includes a retainer 602 whichis secured upon the face of a patient by a harness 604. The harness 604retains the retainer 602 in the operative position to support anendo-tracheal tube. The illustrated retainer 602 is the same retainerdescribed with reference to FIGS. 19-29. The harness 604 is similar tothe harness described with reference to FIG. 16 except that the headcontact member 606 illustrated in FIG. 16 is made of interconnectedstraps in the embodiment illustrated in FIG. 32. Further, the attachmentmembers 708 are similar to the attachment member 608 except that thesecond ends are preferably integral with the strap head contact member706.

While not illustrated in FIGS. 16 and 32, the first end portion of theattachment members 608, 708 may be integral with the retainer 602 andthe second end portion of the attachment members 608 may be integralwith the head contact member 606. In embodiments having integral orfixed first or second ends, the attachment members 608, 708 may comprisean elastic material which keeps the attachment members 608, 708 tautbetween the back of the patient's head and the retainer 602 bystretching the attachment members 608, 708. Alternatively or incombination with an elastic portion, the attachment members 608, 708 mayinclude adjustment means for changing the length of the attachmentmembers 608, 708 between the integral or fixed first or second ends. Theadjustment means may be a mechanical system which allows the medicalattendant to change the length of the attachment members 608, 708between the head contact member 606, 706 and the retainer 602. Otheradjustment means include but are not limited to: snaps, clips, Velcro,or such other fasteners as are known to those of skill in the art.

In the exemplary embodiment illustrated in FIG. 32, the strap headcontact member 706 includes securing regions 610 a, 610 b, 610 c, 610 d.The securing regions 610 integrally attach the attachment members 708 tothe strap head contact member 706.

Each attachment member 708 comprises a first end portion and a secondend portion. In certain embodiments, the first end portion has a hookand loop fastener. The first end portion is configured for attachment tothe securing locations 618 of the retainer 602 (see FIG. 19). The secondend portion of the attachment member 708 is configured for attachment tothe securing regions 610 of the strap head contact member 706. Incertain embodiments, at least a portion of each attachment member 708comprises a flexible material. For example, the attachment member 708may comprise VELSTRETCH made by Velcro USA Inc. located in NewHampshire.

The harness 604 which secures the retainer 602 to the patient's face foruse includes a strap head contact member 706 which generally encirclesat least a portion of the patient's skull as illustrated in FIG. 35. Incertain embodiments, the strap head contact member 706 has the shape ofa closed loop and is sized to receive a portion of the skull of apatient. In certain embodiments, the strap head contact member 706encircles the lambda of the patient's skull. In certain embodiments, thestrap head contact member 706 spans across at least the sagittal sutureof the patient's skull. In preferred embodiments, when positioned withthe attachment members 708 in tension, the head contact member 706exerts pressure on the occipital bone, and preferably also on theparietal bone.

Preferably, the loop of the strap head contact member 706 is smallerthan the patient's skull and restricts the skull from passing entirelythrough the center of the loop. While the illustrated embodiment of thestrap head contact member 706 has a fixed sized opening, in certainembodiments the strap head contact member 708 includes overlapping endshaving suitably, infinitely adjustable fastening means, such as hook andloop fasteners (e.g., VELCRO, fastener pads) whereby the strap headcontact member 706 may be adjusted to firmly and snuggly encompass aportion of the patient's head.

In certain embodiments, the strap head contact member 706 includes amiddle strap (not shown) which extends across the center opening of thestrap head contact member 706.

For embodiments having an integral harness 604 and attachment members708, the first end portions of the attachment members 708 are adjustedto fit the securement system to the patient. The described harness 604provides for firm securement of the retainer 602 in its use position bymeans of an adjustable fit whereby the patient's head movement orexternal manipulation of the endo-tracheal tube 10 result in minimaldisturbance of the endo-tracheal tube 10 in the patient's airway.

FIGS. 34 and 35 illustrate the use of the securement system of FIG. 32upon a patient. FIG. 34 shows the upper attachment members 708 alignedwith the retainer 602 and spaced 90 degrees apart and the lowerattachment members 708 aligned with the retainer 602 and spaced 90degrees apart to ease access to the sides of the mouth while providingstability to the retainer 602 on the patient's face. FIG. 35 shows thestrap head contact member 708 encircling at least a portion of thepatient's skull.

In FIG. 34, the opposing concave sections of the anchor feet 626, 632(see FIGS. 19 and 23) create a notch or cutout proximate to the centerof the retainer 602. As a result, the notched regions of the anchor feet626, 632 provide clearance to access the sides of the patient's mouthfor oral care and other nursing care as required. The outwardlyextending wide regions of the anchor feet 626, 632 provide stability onthe patient's mouth. As illustrated in FIG. 34, the posterior facingsurface 620 of the retainer is disposed superior and inferior relativeto the midline of the lips.

FIG. 36 illustrates another preferred embodiment of a securement system800. The embodiment illustrated in FIGS. 36 through 47 is similar to theembodiment described with reference to FIGS. 16 through 31 except thatthe embodiments of the retainers 602, 802 and of the attachment members608, 808 are not the same. Furthermore, the attachment members 608, 808attach differently to the retainers 602, 608 for the differentembodiments. Features and structure similar to both embodiments areidentified with the same last two digits (for example, 608 and 808) forease of explanation. Thus, the detailed description for features of thesecurement system 600 applies with equal force to the similar featuresfound in the securement system 800.

The securement system 800 includes a retainer 802 which is secured uponthe face of a patient by a harness 804. The harness 804 which securesthe retainer 802 to the patient's face includes a head contact member606 and attachment members 808 for use in the described securementsystem 800.

Each attachment member 808 comprises a first end portion and a secondend portion. In certain embodiments, the first end portion has a hookand loop fastener. The first end portion is configured for attachment tothe retainer 802. The second end portion of the attachment member 808 isconfigured for attachment to the securing regions 610 of the headcontact member 606.

The retainer 802 comprises a first portion 812 and a second portion 814.The first portion 812 is configured to engage with the second portion814 forming a tubular channel 816 therebetween (see FIG. 37). Thechannel 816 is configured to receive a portion of the endo-tracheal tube10 so as to inhibit movement of the endo-tracheal tube 10 relative tothe retainer 802.

The retainer includes a plurality of securing locations 818 located onthe first and second portions 812, 814 (see FIG. 37). Each of the firstand second portions 812, 814 comprises at least one securing location818. The securing locations 818 are configured for attachment to thefirst ends of the attachment members 808. The width of the securinglocation 818 may be sized to accommodate the width of the attachmentmember 808. For example, the width of the attachment member 808 can beequal to or less than the width of the securing location 818 tofacilitate threading of the first end around the securing location 818.In the illustrated embodiment, the width of the attachment member 808necks down near the first end. In certain embodiments, the securinglocations 818 are located superior and inferior to the lips of thepatient when the retainer 802 is placed upon the patient's mouth.

To facilitate attachment of the attachment members 808, the first andsecond portions 812, 814 may include ramps 846 (see FIGS. 44-47). Theramps 846 provide a curved surface to preferentially direct the firstend of the attachment member 808 around the securing location 818 whenassembling the securement system 800.

A posterior facing surface faces the head contact member 806 when wornby a patient and is configured to inhibit longitudinal movement of theretainer 802 into a patient's mouth. In certain embodiments, theposterior facing surface 820 is disposed superior and inferior relativeto the midline of the lips so as to allow access to the sides of themouth.

FIG. 37 illustrates a top view of a two piece retainer 802 of thesecurement system of FIG. 36. FIG. 38 illustrates a bottom view of theretainer 802. The retainer 802 fastens or connects to the endo-trachealtube 10. The securing locations 818 attach to the attachment members808.

FIG. 39 illustrates a side view of the retainer of FIG. 37 having afirst finger pressure surface 822. FIG. 40 illustrates an opposite sideview of the retainer of FIG. 37 having a second finger pressure surface824. The first and second finger surfaces 822, 824 provide regions for amedical attendant to squeeze the first portion 812 and the secondportion 814 together to form the retainer 802.

FIG. 41 illustrates a side view of the two-piece retainer of FIG. 37with a first portion 812 engaged with a second portion 814. Each of thefirst and second portions 812, 814 is a one-piece molding of plasticsmaterial. Each portion 812, 814 includes a groove as described below.

FIGS. 44 and 45 illustrate perspective views of a first portion 812 ofthe retainer of FIG. 37. The first portion 812 comprises an anchor foot826, a pair of transversely extending parallel flexible prongs 828, 830,and the securing locations 818. The prongs 828, 830 are preferablyintegrally formed with the first portion 812.

FIGS. 46 and 47 illustrate perspective views of a second portion 814 ofthe retainer of FIG. 37. The second portion 814 comprises an anchor foot832, a pair of transversely extending parallel receptacles or apertures834, 836, and securing locations 818. The receptacles 834, 836 areconfigured to receive the prongs 828, 830 of the first portion 812. Inthe illustrated embodiment, the anchor feet 826, 832 (see FIGS. 37 and41) desirably include a pair of opposing concave sections that narrowthe center of the anchor feet 826, 832 proximate to the center of theretainer 802.

The two portions 812, 814 are adapted to be engaged, as shown in FIG.37, to form a tubular channel 816 therebetween for receiving theendo-tracheal tube 10. Once engaged, the first and second portions arelaterally slidable together so as to reduce the channel 816cross-section and firmly grip the endo-tracheal tube 10. The first andsecond portions are inhibited from sliding apart by interengagingstructure as described below.

The channel 816 is formed by respective hemispherical grooves in theportions 812, 814. As best seen in FIGS. 42 and 43, the grooves have aconsistent width along the longitudinal axis. In certain embodiments,the grooves vary in width (i.e., in the lateral direction) along theirlongitudinal lengths.

To firmly hold the endo-tracheal tube 10 within the channel 816, theretainer 802 includes interengaging structure. The interengagingstructure inhibits the first portion 812 and second portion 814 fromslidingly disengaging from one another. The interengaging structure maybe releasable or not.

In the illustrated embodiment and as best seen in FIGS. 44-47, theinterengaging structure is a releasable latch mechanism. The latchmechanism is used to secure the first portion 812 to the second portion814. In the illustrated embodiment, the latch mechanism comprisesinterfitting teeth 838 (see FIGS. 44 and 45) provided on prongs 828, 830and a pair of receptacles 834, 836 (see FIGS. 46 and 47) ofcomplementary shape to the prongs. Each receptacle 834, 836 includes aninner edge which locks with the teeth 838 on the prong 828, 830. Theinner edges of the receptacles 834, 836 snap against the teeth 838 whenthe prongs 828, 830 are inserted through the receptacles 834, 836forming the closed position.

In FIG. 39 the prongs 828, 830 are shown inserted through thereceptacles 834, 836. The prongs 828, 830 interact with the receptacles834, 836 formed in the second portion 814 to secure the prongs 828, 830in their operative positions inhibiting the first portion 812 frommoving away from the second portion 814.

FIGS. 42 and 43 illustrate perspective views of the retainer 802 of FIG.37. As seen in FIG. 43, prongs 828, 830 have been inserted throughreceptacles 834, 836 and the prong teeth 838 engage with correspondingedges or teeth on the second portion 814 to clamp the endo-tracheal tube10 in place within the channel 816.

For embodiments having releasable interengaging structure, theinterengagement is released to allow the retainer portions 812, 814 tobe separated, thereby permitting removal and replacement of anendo-tracheal tube 10 within the channel 816 of the retainer 802. Incertain embodiments, a medical attendant presses downward on platforms844 (see FIGS. 42 and 43) to disengage the prongs 828, 830 from theinner edges and slides the first portion 812 away from the secondportion 814.

Securement barbs 842, adhesive spots, surface treatments, and frictionridges can be used to retain the endo-tracheal tube 10 in thelongitudinal direction. The retainer can include only one retentionmember or possibly several; it need not include all. In addition, anycombination of the retention members (for example, an adhesive spot andsecure barbs) in the retainer is also possible.

FIG. 48 illustrates another preferred embodiment of a securement system900. The securement system 900 includes a retainer 802 which is securedupon the face of a patient by a harness 804. The illustrated retainer802 is the same retainer described with reference to FIGS. 37-47. Theharness 804 is similar to the harness described with reference to FIG.32-35 except that the width of the attachment members 908 illustrated inFIG. 48 necks down near the first end. Similar features and structure tothe embodiments are identified with the same last two digits (forexample, 708 and 908) for ease of explanation. Thus, the detaileddescription for features of the securement systems 700, 800 applies withequal force to the similar features found in the securement system 900.

In the exemplary embodiment illustrated in FIG. 48, the strap headcontact member 706 includes securing regions 610 a, 610 b, 610 c, 610 d.The securing regions 610 integrally attach the attachment members 908 tothe strap head contact member 706.

Each attachment member 908 comprises a first end portion and a secondend portion. The first end portion is configured for attachment to thesecuring locations 818 of the retainer 802. The second end portion ofthe attachment member 908 is configured for attachment to the securingregions 610 of the strap head contact member 706.

The harness 804 which secures the retainer 802 to the patient's face foruse includes a strap head contact member 706 which generally encirclesat least a portion of the patient's skull as illustrated in FIG. 50. Incertain embodiments, the strap head contact member 706 has the shape ofa closed loop and is sized to receive a portion of the skull of apatient. In certain embodiments, the strap head contact member 706encircles the lambda of the patient's skull. In certain embodiments, thestrap head contact member 706 spans across at least the sagittal sutureof the patient's skull.

FIGS. 49 and 50 illustrate the use of the securement system of FIG. 48upon a patient. FIG. 49 shows the attachment members 908 aligned withthe retainer 802 and spaced 90 degrees apart to ease access to the sidesof the mouth while providing stability to the retainer 802 on thepatient's face. FIG. 50 shows the strap head contact member 908encircling at least a portion of the patient's skull.

FIG. 51 illustrates the use of another embodiment of a securement system1000 upon a patient and shows a crossover attachment member 1002connecting an upper attachment member 608 to a lower attachment member608. The embodiment illustrated in FIG. 51 is similar to the embodimentdescribed with reference to FIGS. 16 through 31 except that each pair ofattachment members 608 located on the left and right sides of thepatient's head are coupled together via a crossover attachment member1002. Features and structures similar to both embodiments are identifiedwith the same identifiers for ease of explanation. Thus, the detaileddescription for features of the securement system 600 applies equally tothe similar features found in the securement system 1000.

The securement system 1000 includes a retainer 602 which is secured uponthe face of a patient by a harness 604. The harness 604 which securesthe retainer 602 to the patient's face includes a head contact member606, attachment members 608, and crossover attachment members 1002 foruse in the described securement system 1000.

Each crossover attachment member 1002 comprises a first end portion anda second end portion. In certain embodiments, the first end portion isfixedly attached to the upper attachment member 608 that is locatedabove the ear. The crossover attachment member 1002 is wrapped aroundthe lower attachment member 608 located below the ear and then aroundthe upper attachment member 608. The second end portion has hook or aloop region upon which the hooks or the loops of a hook and loopfastener are disposed. The crossover attachment member 1002 has a secondhook or a loop region for fastening to the second end portion.

Alternatively, the first end portion is fixedly attached to theattachment member 608 that is located below the ear. The crossoverattachment member 1002 is wrapped around the attachment member 608located above the ear and then around the attachment member 608 locatedbelow the ear. The hook or loop region of the second end portionattaches to the crossover attachment member 1002.

While not illustrated in FIG. 51, the first end portion of the crossoverattachment member 1002 may be integral with the upper attachment member608 and the second end portion of the crossover attachment member 1002may be integral with the lower attachment member 608. Such an embodimentis illustrated in FIG. 52 in combination with a different preferredembodiment of a securement system 1100, which will be described ingreater detail below. In embodiments having integral or fixed first orsecond ends, the crossover attachment members 1002 may comprise anelastic material which keeps the crossover attachment members 1002 tautbetween the upper attachment member 608 and the lower attachment member608 by stretching the crossover attachment member 1002.

Alternatively or in combination with an elastic portion, the crossoverattachment member 1002 may include adjustment means for changing thelength of the crossover attachment member 1002 between the integral orfixed first or second ends. Such an embodiment is illustrated in FIG. 53in combination with a securement system 1200, which will be described ingreater detail below. The adjustment means may be a mechanical systemwhich allows the medical attendant to change the length of the crossoverattachment member 1002 between the upper attachment member 608 and thelower attachment member 608. Other adjustment means include but are notlimited to: snaps, clips, Velcro, or such other fasteners as are knownto those of skill in the art.

In the illustrated embodiment, the crossover attachment member 1002 islocated between the patient's lips and ear with a portion of thecrossover attachment member 1002 being located superior and inferior tothe lips of the patient. When connecting the lower and upper attachmentmembers 608, the crossover attachment member 1002 inhibits the lowerattachment member 608 from migrating in a downward direction and overthe mandible or jaw bone. In this way, the crossover attachment member1002 inhibits the lower attachment member 608 from hooking around themandible or jaw bone and moving the endo-tracheal tube within the throatof the patient in response to movement of the mandible or jaw bone.Inward motion of the tube is undesirable because it will eventuallyresult in the tube moving down one of the patient's bronchi, preventingair from being ventilated to the other lung. This will quickly lead tothe collapse of the unventilated lung. Even slight back and forth motionof the tube within the throat can result in tracheomalacia andultimately in the weakening or collapse of the trachea, which mayrequire permanent stenting to maintain an open airway. Migration mayfurther result in Ventilator-Associated Pneumonia (VAP). With thesecurement system 1000, movement of the mandible or jaw bone relative tothe skull will not appreciably affect the tension in the attachmentmember 608. Other preferred embodiments of the crossover attachmentmember are described with references to FIGS. 52 and 53.

A medical attendant can secure an endo-tracheal tube 10 (or othermedical article) to a patient using the above-described securementsystem (or a readily apparent modification thereof). The medicalattendant places the patient's head on the head contact member 606 orbrings the head contact member 606 in contact with the patient's head.

The medical attendant wraps the attachment members 608 around a portionof the patient's head and towards the patient's face. The first endportion of the attachment member 608 is attached to the retainer 602.Two attachment members 608 attach to the first portion 612 while twoother attachment member 608 attach to the second portion 614. The secondend portion of the attachment member 608 is attached to the securingregions 610 of the head contact member 606. Preferably, the attachmentmembers 608 are attached to the head contact member 606 before beingattached to the retainer 602. The medical attendant wraps the second endportions of the crossover attachment members 1002 around the two lowerattachment members 608 and then back around the two upper attachmentmembers 608. The second end portions are then attached to the crossoverattachment members 1002 using the hook and loop fasteners.

When in place, the lower two attachment members 608 are disposed beneaththe ears, while the upper two attachment members 608 are disposed abovethe ears and cross over the temples of the patient. Further, thecrossover attachment members 1002 connect the two upper attachmentmembers 608 to the two lower attachment members 608 at a locationbetween the lips and the ears so as to inhibit movement of the lowerattachment straps 608 towards the mandible or jaw bone. With thesecurement system 1000, movement of the mandible or jaw bone relative tothe skull will not appreciably affect the tension in the attachmentmember 608.

FIG. 52 illustrates the use of another embodiment of a securement system1100 upon a patient and shows a crossover attachment member 1102 fixedlyattached at its ends to both the upper attachment member 708 and thelower attachment member 708. The embodiment illustrated in FIG. 52 issimilar to the embodiment described with reference to FIGS. 32 through35 except that each pair of attachment members 708 located on the leftand right sides of the patient's head are coupled together via acrossover attachment member 1102. Features and structures similar toboth embodiments are identified with the same identifiers for ease ofexplanation. Thus, the detailed description for features of thesecurement system 700 applies with equal force to the similar featuresfound in the securement system 1100.

The securement system 1100 includes a retainer 602 which is secured uponthe face of a patient by a harness 604. The harness 604 which securesthe retainer 602 to the patient's face includes a strap head contactmember 706, attachment members 708, and crossover attachment members1102 for use in the described securement system 1100. The strap headcontact member 706 generally encircles at least a portion of thepatient's skull as illustrated in FIG. 35. The harness 604 retains theretainer 602 in the operative position to support an endo-tracheal tube10.

Each crossover attachment member 1102 comprises a first end portion anda second end portion. The first end portion of the crossover attachmentmember 1102 is fixedly attached or integral with the upper attachmentmember 708 and the second end portion of the crossover attachment member1102 is fixedly attached or integral with the lower attachment member708.

While the illustrated embodiment of the crossover attachment member 1102has a fixed length, in certain embodiments the crossover attachmentmember 1102 includes overlapping ends having suitably, infinitelyadjustable fastening means, such as hook and loop fasteners (e.g.,VELCRO, fastener pads) whereby the crossover attachment member 1102 maybe adjusted to selectively locate the lower attachment member 708 at asufficient distance from the bottom of the mandible or jaw bone so as toinhibit movement of the lower attachment member 708 when the mandible orjaw bone moves. Such an embodiment is illustrated in FIG. 53.

The crossover attachment members 1102 illustrated in FIG. 52 maycomprise an elastic material which keeps the crossover attachmentmembers 1102 taut between the upper attachment member 708 and the lowerattachment member 708 by stretching the crossover attachment members1102. For example, the crossover attachment member 1102 may compriseVELSTRETCH made by Velcro USA Inc. located in New Hampshire.

For embodiments having an integral harness 604, attachment members 708,and crossover attachment members 1102, the first end portions of theattachment members 708 are adjusted at the retainer 602 to fit thesecurement system to the patient. The described harness 604 andcrossover attachment members 1102 provide for firm securement of theretainer 602 in its use position by means of an adjustable fit wherebythe patient's head movement, mandible movement, or external manipulationof the endo-tracheal tube 10 result in minimal disturbance of theendo-tracheal tube 10 in the patient's airway.

FIG. 53 illustrates the use of another embodiment of a securement system1200 upon a patient and shows a multi-piece, crossover attachment member1202(a), 1202(b). The embodiment illustrated in FIG. 53 is similar tothe embodiment described with reference to FIG. 52 except that eachcrossover attachment member 1202(a), 1202(b) includes adjustment meansfor changing the length of the attachment member 1202(a), 1202(b)between the integral or fixed first and second ends. In the illustratedembodiment, the adjustment means is provided by a two-piece, crossoverattachment member 1202(a), 1202(b). While not illustrated, theadjustment means may be a mechanical system which allows the medicalattendant to change the length of the crossover attachment member1202(a), 1202(b) between the upper attachment member 708 and the lowerattachment member 708. Other adjustment means include but are notlimited to: snaps, clips, Velcro, or such other fasteners as are knownto those of skill in the art.

Each crossover attachment member 1202(a), 1202(b) comprises a firstportion 1202(a) and a second portion 1202(b). In the illustratedembodiment, regions of the first and second portions have a hook andloop fastener. The first portion 1202(a) is configured for attachment tothe second portion 1202(b). In certain embodiments, at least a portionof the first portion 1202(a) and/or the second portion 1202(b) comprisesa flexible material such as, for example, VELSTRETCH.

For embodiments having an integral harness 604, attachment members 708,and crossover attachment members 1202, the first end portions of theattachment members 708 at the retainer 602 along with the first andsecond portions 1202(a), 1202(b) of the crossover attachment members1202 are adjusted to fit the securement system to the patient. Thedescribed harness 604 and crossover attachment members 1102 provide forfirm securement of the retainer 602 in its use position by means of anadjustable fit whereby the patient's head movement, mandible movement,or external manipulation of the endo-tracheal tube 10 result in minimaldisturbance of the endo-tracheal tube 10 in the patient's airway. Withthe securement system 1200, movement of the mandible or jaw bonerelative to the skull will not appreciably affect the tension in theattachment member 608.

FIG. 54 illustrates a top view of another preferred embodiment of aretainer 1302. FIG. 55 illustrates a bottom view (i.e., the side facingtowards the patient) of the retainer 1302. The retainer 1302 is similarto the retainer 602 described with reference to FIG. 19 except that theretainer 1302 includes a bit block 1304 on a proximal side of theretainer 1302. At least a portion of the bite block 1304 extends belowthe anchor feet 626, 632 and into the patient's mouth. The bite block1304 preferably prevents the patient from occluding with his teeth theendo-tracheal tube 10 passing through the channel 616. In theillustrated embodiment, the first portion 612 of the retainer 1302includes a first portion of the bite block 1304(a). The second portionof the retainer 1302 includes a second portion of the bite block1304(b). Alternatively, the first portion 612 or the second portion 614of the retainer 1302 includes the entire bite block 1304.

The bite block 1304 has a longitudinal bore (or passageway or channel)that preferably is aligned with, or integral to, the channel 616 passingthrough the retainer 1302. The portion of the longitudinal bore orchannel 616 passing through the bite block 1304 can have a greaterdiameter than other portions of the channel 616. Because the portion ofthe channel 616 located on the distal side of the anchor feet 626, 632clamps to the endo-tracheal tube 10 so as to inhibit longitudinalmovement of the endo-tracheal 10 relative to the retainer 1302, theportion of the channel 616 passing through the bite block 1304 need notclamp against the endo-tracheal tube 10. Additionally, because thepatient's teeth will typically be able to exert a force on theendo-tracheal tube 10 in a limited direction, the bite block 1304 neednot be disposed around the entire periphery of the endo-tracheal tube10.

The bite block 1304 need only extend from one or both of the anchor feet626, 632 so as to be disposed on generally opposite sides of thelongitudinal axis near to the upper and lower front teeth of thepatient. Preferably, portions of the bite block 1304 are located betweenthe upper teeth and the endo-tracheal tube 10 and the lower teeth andthe endo-tracheal tube 10 when the retainer 1302 is installed on thepatient. For example, a portion of the bite block 1304(a) can beintegral with the first portion 612 of the retainer 1302 and extend fromthe anchor foot 626 in a proximal, longitudinal direction on a side ofthe longitudinal axis so as to be disposed between the teeth of theupper jaw and the endo-tracheal tube 10. Likewise, a portion of the biteblock 1304(b) can be integral with the second portion 614 of theretainer 1302 and extend from the anchor foot 632 in a proximal,longitudinal direction on a side of the longitudinal axis so as to bedisposed between the teeth of the lower jaw and the endo-tracheal tube10. Together, both portions of the bite block 1304(a), 1304(b) inhibitthe patient from biting into or occluding the endo-tracheal tube 10.

The bite block 1304 extends a sufficient distance below the anchor feet626, 632 and into the patient's mouth so that a proximal portion of thebite block 1304 is disposed between the upper and lower front teeth ofthe patient. Preferably, the bite blocks 1304 extends in a proximaldirection past the upper and lower front teeth so that if the patientshifts or moves their jaws in a proximal, longitudinal direction, thefront teeth do not slide over the proximal end of the bite block 1304and contact the endo-tracheal tube 10.

The retainer 1302 and the bite block 1304 can be separately formed andthen secured to each other, or they can be integrally formed with eachother, depending upon the materials of which they are made. Preferably,the bite block 1304 is integral with the retainer 1302 such that thechannel 616 is aligned with and able to communicate with the channel 616or bore of the bite block 1304. Alternatively, the bite block 1304extends through at least a portion of the channel 616 in the retainer1302 and is secured to the inner wall of the channel 616 by bonding, forexample, if not integrally formed with the retainer 1302. In anotheralternative embodiment, the bite block 1304 is spaced from the proximalend of the retainer 1302 and releasably connectable to the retainer1302.

It may be convenient if one or both of the retainer 1302 and the biteblock 1304 is made of a see-through material, such as a transparentplastic, to enable the condition of a patient's mouth to be readilyobserved for obstructions, contamination, or damage.

The retainer 1302 shown in FIG. 54 shows the securing locations 618arranged such that the plane of the opening of the securing locations isparallel to the posterior surface 620 of the retainer 1302. However,those of skill in the art will recognize that the plane of the openingsneed not be oriented in this direction. The openings could also beinclined relative to the posterior or bottom surface. Those of skill inthe art will also recognize that various angled arrangements for thesecuring locations 618 are also possible, and that the planes of theopenings for the securing locations 618 need not be oriented in the samedirection relative to the posterior surface 620.

In order to use the retainer 1302, the first portion 612 and integralbite block portion 1304(a) is separated from the second portion 614 andintegral bite block portion 1304(b). Once separated, the first portion612 and the second portion 614 are aligned with the endo-tracheal tube10 therebetween. The endo-tracheal tube 10 may first be placed, forexample, within the groove or channel portion 616 formed by the firstportion 612 and the bite block 1304(a). The second portion 614 and biteblock 1304(b) are then engaged with the first portion and completes thechannel 616. The desired channel shape for such a retainer issubstantially similar to the shape of the endo-tracheal tube 10.

With the first and second portions engaged, the retainer is disposedupon the endo-tracheal tube 10 and results in the configuration shown inFIG. 66. Once the retainer 1302 is mounted upon the endo-tracheal tube10 and the strap head contact member 706 is placed on the opposite sideof the patient's skull, the attachment members 708 can be used to adjustthe tension between the retainer 1302 and the strap head contact member706.

The retainer 1302 and bite block 1304 can be formed of a somewhatflexible material which tends to hold its shape, but which can be flexedor bent by a medical practitioner without fracturing. Suitable rigid butflexible materials include, for example, but without limitation,plastics, polymers or composites such as polypropylene, polyethylene,polycarbonate, polyvinylchloride, acrylonitrile butadiene styrene,nylon, olefin, acrylic, polyester, as well as moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. The illustrated retainer 1302 preferably is formed byinjection molding using polyethylene or polypropylene material or nylon.However, other materials can be utilized.

FIG. 56 illustrates a side view of the retainer of FIG. 54 having afirst finger pressure surface 622. FIG. 57 illustrates an opposite sideview of the retainer of FIG. 54 having a second finger pressure surface624. The first and second finger surfaces 622, 624 provide regions for amedical attendant to squeeze the first portion 612 and the secondportion 614 together to form the retainer 1302. The retainer 1302 isfirst placed in the desired position longitudinally upon theendo-tracheal tube 10. The retainer is then squeezed around theendo-tracheal tube 10 so as to grip the outer surface of theendo-tracheal tube 10 even without the use of adhesive. Such anarrangement is advantageous in circumstances where it becomes desirableto reposition the retainer 1302 upon the endo-tracheal tube 10.

In order to improve traction between the retainer 1302 and theendo-tracheal tube 10, the outer surface of the endo-tracheal tube 10can be roughened, or otherwise treated with a high friction coating toprovide a better grip between the endo-tracheal tube 10 and retainer1302. This will help inhibit any undesired motion of the retainer 1302upon the endo-tracheal tube 10 once the retainer 1302 is in position.

FIG. 58 illustrates a side view of the two-piece retainer and integralbite block of FIG. 54 with a first portion 612 engaged with a secondportion 614. Each of the first and second portions 612, 614 is aone-piece molding of plastics material. Each portion 612, 614 includes agroove as described below. As best illustrated in FIGS. 56 through 58,the posterior surfaces 620 (facing the patient) are preferablycontoured. The contour can be selected to follow the curvature of thepatient's face. Advantageously, a contoured surface that follows thecurves of the patient's face increases the contact area between theretainer 1302 and the patient's face and evenly distributes the weightof the retainer 1302 and any tension from the attachment members 708.

FIGS. 61 and 62 illustrate perspective views of a first portion 612 ofthe retainer of FIG. 54. The first portion 612 comprises an anchor foot626, a pair of transversely extending parallel flexible prongs 628, 630,a first bite block portion 1304(a), and securing locations 618. Theprongs 628, 630 are preferably integrally formed with the first portion612. In FIGS. 54 through 60, prongs 628, 630 are shown engaged with thesecond portion 614 to secure an endo-tracheal tube 10 in place.

FIGS. 63 and 64 illustrate perspective views of a second portion 614 ofthe retainer of FIG. 54. The second portion 614 comprises an anchor foot632, a pair of transversely extending parallel receptacles or apertures634, 636, a second bite block portion 1304(b) and securing locations618. The receptacles 634, 636 are configured to receive the prongs 628,630 of the first portion 612.

The two portions 612, 614 are adapted to be engaged, as shown in FIG.54, so as to define a tubular channel 616 therebetween for receiving theendo-tracheal tube 10. The channel 616 is formed by respective generallyhemispherical grooves in the first and second portions. Once engaged,the first and second portions are laterally slidable together so as toreduce the channel 616 cross-sectional area and firmly grip theendo-tracheal tube 10. The first and second portions are inhibited fromsliding apart by interengaging structure as described below.

Each groove has a generally hemispherical cross-sectional shape. As bestseen in FIGS. 54 and 55, the groove has a uniform width along thelongitudinal axis. In certain embodiments, the groove varies in width(i.e., in the lateral direction) along its longitudinal length. That is,in certain embodiments, the side walls of the groove diverge from eachother in, for example, a generally linear manner from one longitudinalside of the retainer 1302 to the other longitudinal side of theretainer.

To firmly hold the endo-tracheal tube 10 within the channel 616, theretainer 1302 includes interengaging structure. The interengagingstructure inhibits the first portion 612 and second portion 614 fromslidingly disengaging from one another. The interengaging structure canbe releasable or not.

In the illustrated embodiment, the interengaging structure is areleasable latch mechanism. The latch mechanism is used to secure thefirst portion 612 to the second portion 614. In the illustratedembodiment, the latch mechanism comprises interfitting teeth 638provided on prongs 628, 630 and a pair of receptacles 634, 636 ofcomplementary shape to the prongs. Each receptacle 634, 636 includes aninner edge which locks with the teeth 638 on the prong 628, 630. Theinner edges of the receptacles 634, 636 snap against the teeth 638 whenthe prongs 628, 630 are inserted through the receptacles 634, 636forming the closed position. In the illustrated embodiment, the latchmechanism is formed with the retainer 1302 as a unitary piece. In otherembodiments, however, other types of interengaging structure can also beused.

For embodiments having releasable interengaging structure, the structureis simply released to remove, reposition or replace an endo-trachealtube 10 within the channel 616 of the retainer 1302. In certainembodiments, a medical attendant presses downward on platforms 644 todisengage the prongs 628, 630 from the inner edges and slides the firstportion 612 away from the second portion 614. The platforms 644 pivottowards the longitudinal axis and contact the outer surface of theprongs 628, 630. Further pressure on the platforms 644 deflects theprongs 628, 630 away from the edges of the receptacles 634, 636 andtowards the longitudinal axis. As the prongs 628, 630 move towards thelongitudinal axis, the teeth 638 disengage from the edges of thereceptacles 634, 636 releasing the first portion 612 from the secondportion 614. While maintaining pressure on the platforms 644, themedical attendant separates the first portion 612 from the secondportion 614. The medical attendant can then open the retainer 1302 andexpose the channel 616.

The same retainer 1302 can be used multiple times on the patient, so asto permit repeated attachment and reattachment of the endo-tracheal tube10 to the securement system 600. In addition, the medical attendant canuse the retainer 1302 with any of a wide variety of size tubes. Inaddition, the bite block 1304 being integral with the retainer 1302ensures that the bite block 1304 will not be lost or misplaced if theendo-tracheal tube 10 is detached from the securement system.

The grooves formed in the first and second portions 612, 614 define thechannel 616 when the retainer 1302 is in a closed position. The channel616 is capable of receiving a portion or length of the endo-trachealtube 10 and is generally configured to house, grip and secure theendo-tracheal tube 10 in one or more contact areas of the channel 616.The contact area(s) can be located on one or both longitudinal sides ofthe anchor feet 626, 632 along the longitudinal axis of the channel 616.The channel 616 can have a variety of configurations, as discussed abovein connection with the grooves in order to accommodate a particulartube. As the interengaging structure provides multiple positions for thefirst and second portions 612, 614 relative to each other, and thusmultiple channel widths, to lock the first portion 612 to the secondportion 614, a single retainer 1302 can accommodate many different sizetubes. In the illustrated embodiment, the channel 616 generally has agenerally circular, cross-sectional shape through the bite block 1304.

In the embodiment illustrated in FIGS. 54-64, the sides of the channel616 are generally straight and parallel with each other. The walls ofthe channel 616 (and, thus, the grooves of the first portion 612 andsecond portion 614), however, need not be straight. For example, thewall of the first portion groove can have a convex section that narrowsthe portion of the channel so as to correspond in shape to the shape ofthe received portion of the endo-tracheal tube 10. This channel shapefurthers retention of the endo-tracheal tube 10 within the channel 616to inhibit endo-tracheal tube 10 movement through the channel.Similarly, the shape of the channel can be selected (e.g., curved) toarrest movement of the endo-tracheal tube 10 through the retainer 1302.

Although the channel 616 can take the form of various shapes dependingupon its application (i.e., depending upon a shape of the tube portionof the medical article for which the retainer is designed to be used),the channel 616 does have a sufficient length in the longitudinaldirection to stabilize the endo-tracheal tube 10, rather than act as afulcrum for the endo-tracheal tube 10. That is, the retainer 1302receives a sufficient length of the endo-tracheal tube 10 to inhibitmovement of the endo-tracheal tube 10 in the lateral, longitudinal andtransverse direction (i.e., to inhibit yaw, pitch and axial movement ofthe tube), without kinking the endo-tracheal tube 10.

When the first portion 612 is engaged with the second portion 614, asection of the endo-tracheal tube 10 is captured within the retainer1302. Thus, the retainer 1302 at least restricts, if not prevents,lateral and transverse movement of the retained section of theendo-tracheal tube 10. Movement of the endo-tracheal tube 10 in thelongitudinal direction may be desirably enhanced by one or moreretention mechanisms (e.g., channel shape, securement barbs, frictionridges, roughened channel surface, adhesive) associated with the one ormore contact areas of the channel 616 as described above. Further, oneor more of the retention mechanisms may be disposed together orseparately in the one or more contact areas of the channel 616. Forexample, securement barbs can be located on the surface of a portion ofthe longitudinal channel 616 that is located on the distal side of theanchor feet 626, 632 with the portion of the longitudinal channel 616that is located on the opposite side not employing securement barbs orinstead having another retention mechanism on the surface of the channel616.

FIG. 65 illustrates another preferred embodiment of a securement system1300. The securement system 1300 includes a retainer 1302 which issecured upon the face of a patient by a harness 604. The harness 604retains the retainer 1302 in the operative position to support anendo-tracheal tube 10. The illustrated retainer 1302 is the sameretainer described with reference to FIGS. 54-64. The harness 604 is thesame harness described with reference to FIG. 52. Features andstructures similar to both embodiments are identified with the sameidentifiers for ease of explanation. Thus, the detailed description forfeatures of the securement system 1100 applies with equal force to thesimilar features found in the securement system 1300.

FIG. 66 illustrates the use of the securement system 1300 upon a patientand shows a retainer 1304 having a bite block 1304 disposed between thefront upper and lower teeth of the patient. The bite block 1304(a),1304(b) has an elongated, arcuate body defining a proximal portion ofthe channel 616. The channel 616, open at the proximal and distal endsof the retainer 1302, is adapted in size and shape to receive thereinthe endo-tracheal tube 10. The channel 616 is preferably centrallydisposed on the longitudinal axis of the bite block 1304. The contactarea of the channel 616 preferably has a radius larger than, andpreferably only slightly larger than, the outer radius of theendo-tracheal tube or conduit 10.

FIG. 67 is a cross-section view along lines 67-67 in FIG. 66 and showsthe bite block 1304 disposed within the patient's mouth and between thelips and teeth of the upper and lower jaws so as to inhibit the teethfrom contacting and occluding the endo-tracheal tube 10. When viewedfrom the side in cross-section, the length of the bit block 1304 bodygenerally corresponds to a longitudinal distant between an outer surfaceof the patient's lips and the front upper and lower teeth. The biteblock 1304 is sufficiently long so as to permit adjustment of the degreeof insertion of the endo-tracheal tube 1304 in accordance with themedical procedure while keeping the bite block 1304 within biting range.

The thickness of the bite block 1304 (shown in FIG. 67) can be constantor can vary across the longitudinal length of the bite block 1304, butshould provide the bite block 1304 with sufficient rigidity that, inuse, a patient cannot obstruct the endo-tracheal tube 10 seated in thechannel 616. Although the channel 616 defined by the bite block 1304 canbe larger in width than the endo-tracheal tube 10, it is preferred thatthe channel 616 surface and the endo-tracheal tube 10 be in substantialapposition along the full length of the bite block 1304.

The retainer 1302 and bite block 1304 are installed by opening thepatient's mouth and advancing the body of the bite block 1304 thatdefines the proximal portion of the channel 616 into the patient's mouthuntil the posterior facing surface of the anchor feet 626, 632 abutagainst the skin of the oral opening. The contact area of the channel616 surrounds and is preferably in substantial apposition with theendo-tracheal tube 10.

The bite block 1304 can be inserted before or after the retainer 1302 isclamped around the endo-tracheal tube 10. Further, if the retainer 1302is first clamped to the end-tracheal tube 10 prior to insertion of thebite block 1304 into the oral cavity, the medical provided can loosenthe retainer 1302 and re-position the endo-tracheal tube 10 within theretainer 1302 so as to adjust the depth of the proximal end of theendo-tracheal tube 10 within the patient's esophagus. Once adjusted, theproximal portion of the bite block 1304 is preferably disposed betweenthe upper and lower jaws and inhibits the patient from obstructing theendo-tracheal tube 10.

The various embodiments of the securement systems described above inaccordance with the present invention thus provide a means to secure anendo-tracheal tube or other medical article to a patient releasably. Theendo-tracheal tube 10 can be adjusted without removing the entiresecurement assembly, and without the need for use of additional tape tore-secure the endo-tracheal tube 10 once it is properly repositioned. Inaddition, the retainer can be configured to be used with any of a widevariety of tubes and other medical articles. The securement systeminhibits both inward and outward migration of the endo-tracheal tube 10within the patient, and allows for access to the oral cavity of thepatient in order to allow appropriate mouth care to take place.

Of course, it is to be understood that not necessarily all such objectsor advantages may be achieved in accordance with any particularembodiment of the invention. Thus, for example, those skilled in the artwill recognize that the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. In addition to thevariations described herein, other known equivalents for each featurecan be mixed and matched by one of ordinary skill in this art toconstruct securement systems and techniques in accordance withprinciples of the present invention.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

1. An endo-tracheal tube securement system comprising: a head contactmember, at least two upper attachment members, and at least two lowerattachment members, each attachment member extending from the headcontact member, at least portions of the two lower attachment membersbeing configured to lie below a line connecting the lips and ear of apatient when the securement system is installed upon the patient; aretainer comprising a first portion and a second portion, each of thefirst and second portions having a groove, posterior facing surface, anda plurality of securing locations, each groove having a curvilinearshape that together form a channel, the channel being configured toreceive a portion of the endo-tracheal tube so as to inhibit movement ofthe endo-tracheal tube relative to the retainer, the plurality ofsecuring locations being disposed on opposite sides of the channel anddisposed superior and inferior to the lips of the patient when theretainer is placed upon the mouth of the patient, and the posteriorfacing surface being configured to bear upon the lips of the patient andto inhibit movement of the retainer into the patient's mouth, whereinthe at least four attachment members are configured to attach to theplurality of securing locations so as to secure the endo-tracheal tubeto the head contact member; and at least two crossover attachmentmembers, each attaching one of the at least two upper attachment membersto one of the at least two lower attachment members so as to inhibit theat least two lower attachment members from migrating in a downwarddirection and over the mandible or jaw bone of the patient.
 2. Thesystem of claim 1, wherein each crossover attachment member isconfigured to be wrapped about the lower and upper attachment membersand comprises a first end portion and a second end portion, the firstend portion being fixedly attached to the upper attachment member, thesecond end portion having a first hook or a loop region upon which thehooks or the loops of a hook and loop fastener are disposed, and thecrossover attachment member having a second hook or a loop region forfastening to the second end portion.
 3. The system of claim 1, whereineach crossover attachment member comprises a first end portion and asecond end portion, the first end portion being fixedly attached to theupper attachment member, and the second end portion being fixedlyattached to the lower attachment member.
 4. The system of claim 3,further comprising adjustment means for changing the length of thecrossover attachment member between the first end and the second end. 5.The system of claim 4, wherein the crossover attachment member comprisesa first portion and a second portion, the first portion being fixedlyattached to the upper attachment member at the first end and having ahook region upon which the hooks of a hook and loop fastener aredisposed, and the second portion being fixedly attached to the lowerattachment member at the second end and having a loop region upon whichthe Loops of a hook and loop fastener are disposed, wherein an overalllength of the crossover attachment member between the first end and thesecond end is adjustable.
 6. The system of claim 4, wherein theadjusting means comprises snaps.
 7. The system of claim 4, wherein theadjusting means comprises clips.
 8. The system of claim 1, wherein atleast a portion of the crossover attachment members comprises a flexiblematerial.
 9. The system of claim 1, wherein at least a portion of thecrossover attachment member comprises an elastic material.
 10. Thesystem of claim 1, wherein the head contact member comprises an inneropen region configured to receive a portion of a patient's head.
 11. Thesystem of claim 1, wherein the head contact member comprises a strap.12. The system of claim 1, wherein the head contact member has a domeshape.
 13. The system of claim 1, wherein the head contact member issized such that a central portion, when positioned on the skull with theat least two upper attachment members and at least two lower attachmentmembers in tension, places pressure on an occipital bone of the patient.14. The system of claim 13, wherein the central portion places pressureon a parietal bone of the patient.
 15. The system of claim 1 furthercomprising a bite block disposed on generally opposite sides of thechannel and proximal to the posterior facing surface of the retainer.16. A securement system comprising: a head contact member comprising aflexible strap in the form of a closed loop, the loop being sized toreceive a portion of the skull of a patient such that the strapencircles at least the lambda of the skull, the loop being sufficientlysmall to inhibit the skull from passing through the loop; a plurality ofupper straps and a plurality of lower straps attached to the headcontact member; at least two crossover attachment members, eachattaching one of the plurality of upper straps to one of the pluralityof lower straps so as to inhibit the lower straps from migrating in adownward direction and over the mandible or jaw bone of the patient; anda retainer comprising at least two portions, each portion attaching toone of the plurality of upper straps and one of the plurality of lowerstraps, the one of the plurality of lower straps being spaced about 90degrees apart from the one of the plurality of upper straps, theretainer being configured to receive a portion of the medical articlewhen the two portions are engaged so as to inhibit movement of themedical article relative to the retainer.
 17. The system of claim 16,wherein the at least two crossover attachment members are configured tobe wrapped about the lower straps and each comprise a first end portionand a second end portion, the first end portion being fixedly attachedto the upper strap, the second end portion having a first hook or a loopregion upon which the hooks or the loops of a hook and loop fastener aredisposed, and the crossover attachment member having a second hook or aloop region for fastening to the second end portion.
 18. The system ofclaim 16, wherein each of the at least two crossover attachment memberscomprises a first end portion and a second end portion, the first endportion being fixedly attached to the upper strap, and the second endportion being fixedly attached to the lower strap.
 19. The system ofclaim 18, further comprising adjustment means for changing the length ofat least one of the at least two crossover attachment members betweenthe first end and the second end.
 20. The system of claim 19, whereinthe crossover attachment members comprise a first portion and a secondportion, the first portion being fixedly attached to the upper strap atthe first end and having a hook region upon which the hooks of a hookand loop fastener are disposed, and the second portion being fixedlyattached to the lower strap at the second end and having a loop regionupon which the loops of a hook and loop fastener are disposed, whereinan overall length of the crossover attachment member between the firstend and the second end is adjustable.
 21. The system of claim 16 furthercomprising a bite block disposed on generally opposite sides of alongitudinal axis through the retainer and between upper and lower jawsof the patient.
 22. A method comprising: placing a head contact memberon a patient's head, the head contact member being in contact with aplurality of securing straps; wrapping the plurality of securing strapsaround a portion of the patient's head, the plurality of straps being incontact with a retainer having a first portion and a second portion andin contact with a plurality of adjustment straps, at least one of theplurality of straps being in contact with the first portion and at leastanother one of the plurality of straps being in contact with the secondportion; engaging the first portion with the second portion so as toinhibit movement of a medical tube relative to the retainer; andadjusting the length of one or more of the plurality of adjustmentstraps so as to inhibit one or more of the plurality of securing strapsfrom migrating in a downward direction and over the mandible or jaw boneof the patient and so as to locate at least one of the plurality ofsecuring straps superior to the lips of the patient and at least one ofthe securing straps inferior to the lips of the patient.
 23. The methodof claim 22 further comprising placing the medical tube within a biteblock so as to inhibit the patient from occluding the medical tube.